Logistics Manager

Senior Manager Supply Chain

Medical Affairs Lead

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Facilities Security Manager

Quality Control Supervisor

Staff Fiber Optic Test Engineer

Lead Quality Specialist - Investigator

Responsibilities: <ul><li>Supervise logistics staffs to manage their daily operation for the team to achieve a predefined&nbsp;target.</li><li>Manage 3PL’s to handle any operation activities in DC team to meet customer’s requirement and ensure to achieve highest customer’s satisfactory (ECE : Extraordinary Customer Experience)</li><li>Liaise with 3PL’s to monitor DC Workload levels and take necessary actions to ensure the minimum overtime is required but still meet prescribed productivities and service goals.&nbsp;</li><li>Work with 3PL’s to deploy the continuous improvement process and Kaizen activities in DC operation using company OA requirement as a benchmarking.</li><li>Develop, maintain and review physical procedures and standard work for all functional areas of DC to ensure they are up-to-date and match with the actual operation.</li><li>Liaise with Global Trade Services and appointed customs broker to ensure all customs related matters are executed per local customs law/regulation.</li><li>Close cooperation with BU ITCOs for HS Code Classification.&nbsp;</li><li>Coordinate with related parties including company customs broker, DC Operation (3PL’s) and customers/customer’s broker to ensure that customs reports per Malaysia bonded regulation has been prepared and submitted on-time with 100% accuracy.</li><li>Manage carriers/forwarders (all modes; including air, ocean, truck and small package) to deliver shipments to DC/customers on-time. Monitor and be able to scrutinize and on freight spending especially those irregular high spending.&nbsp;</li><li>Manage DC spending to achieve CPC target.</li><li>Being responsible to provide an update to Corporate&nbsp;for any regular cost review.</li><li>Participate in any new system enhancements; e.g. S/4 Hana Implementation, etc. that is related to&nbsp;DC.</li><li>Support any Free Trade Agreement (FTA) Implementation and other requests from Bus/Corporate</li></ul> Requirements: <ul><li>Bachelor’s Degree in any fields with 8-10 years logistics working experience.</li><li>Hands-on experience on DC operation and process improvement. Experience managing 3PL’s&nbsp;would be an advantage.</li><li>SAP Experience on WM is preferred.</li><li>Working knowledge of import/export customs procedures and requirements including licensing,&nbsp;FTA and classification requirements. Experience on customs bonded and LMW is desirable.</li><li>Demonstrated personal leadership of DC teams, demonstrating organizational and management&nbsp;skills, and achieving quality results through team interaction and effective cross-group collaboration&nbsp;(internal and 3PL’s team)</li><li>Strong problem-solving capabilities and the ability to analyze data and use critical thinking to reach&nbsp;logical conclusions and decisions; results oriented; relies on fact-based logic for decision-making</li><li>Ability to communicate with senior management through well formulated presentations and&nbsp;discussions</li><li>Business acumen, a detailed understanding of business processes and the ability to&nbsp;institute/influence change management as needed.</li><li>Proven computer skills in Microsoft suite - Excel, PowerPoint, Word and etc.</li></ul>

Responsibilities: <ul><li>Provide leadership to the purchasing and planning team.&nbsp;</li><li>Responsible for all aspects of raw material use.&nbsp;</li><li>This includes procurement, purchasing, warehousing, and associated transactions in the most commercially effective manner.&nbsp;</li><li>Key KPIs are inventory turns, Aging inventory, Factory orders on time, On-time shipment to customer orders, on-schedule shipment, and material productivity.</li><li>Plans and implements activities related to the timely and cost-effective procurement, inventory control, planning, and quality control of production materials, including oversight and execution of the annual physical inventory take and the annual re-costing process. Responsible for meeting annual material productivity (cost reduction) targets.&nbsp;</li><li>Establishes key performance metrics and benchmarks related to supply chain planning/forecasting to regularly measure actual performance against targets.Ensures the availability of materials in the supply chain to meet the production schedule and maintain inventory at optimum/minimum acceptable levels.&nbsp;</li><li>Responsible for the procurement and supply of raw materials and components.&nbsp;</li><li>Coordinates and integrates the flow of materials and information between suppliers, manufacturers, distributors, and customers.&nbsp;</li><li>Identifies and recommends opportunities to improve the efficiency, effectiveness, and capabilities of the supply chain.</li></ul>&nbsp;Requirements: Education and Experience Requirements: <ul><li>10+ plus years of experience in Supply Chain, Logistics and S&amp;OE Planning.</li><li>Bachelor’s degree in supply chain management, engineering or equivalent. MBA is a plus. Experience in SAP MRP systems.&nbsp;</li><li>IBP demand and supply is a plus.</li><li>APICS or SIOE-P certifications.</li><li>Proven track record of supply chain improvements and related performance improvement results Ability to multi-task, remain highly organize, and thrive in a fast paced and deadline driven environment.</li><li>Ability to communicate complex concepts clearly to cross functional stakeholders.</li><li>Proficiency in Excel, tableau, or related BI digital tools Knowledge and business acumen of Global supply chain logistics and planning and how it affects business P&amp;L.&nbsp;</li><li>Experience working on complex problems and systems that require out of the box solutions.</li><li>Experience in different manufacturing environments (specifically Low volume, High mix and configure/engineered to order)Advance Planning for New Product Introduction experience Lean manufacturing concepts / certification.</li></ul> Preferred Skills and Abilities: <ul><li>Strong leadership and communication skills, able to give direction in cross-functional environment, able to motivate and support colleagues in other functional areas Proven experience in organizational transformation, team leadership and team development Strong analytical and conceptual, problem-solving skills, pragmatic approach (80/20), decision making Committed, entrepreneurial, proactive working attitude (“driver for change”)</li></ul>

Responsibilities: <ul><li>To effectively lead the Medical Affairs activities for segment across therapy areas, providing effective business enablement and high edge scientific activities towards achieving disease and therapy area leadership and enhancing access of products in disease and therapy areas of interest.</li><li>Help in evaluation of New Products for therapy prominence working portfolio and strategy team and marketing team.</li><li>Build connect with KOLs (Key Opinion Leaders) in shaping Therapy understanding and molecule understanding. CME/Ad board conduct ((Continuing Medical Education (CME)/(Medical) Advisory Board)), support guidelines , consensus etc.</li><li>To have scientific activities those are considered differentiated and purposeful for targeted audience.</li><li>Identifying need and planning evidence generation and post marketing studies.</li><li>Guide marketing teams in ensuring proper medical inputs and activities are delivered as per compliance.</li><li>Medico-marketing Support</li><li>Compliance in medico marketing activity</li><li>Evidence generation activities</li><li>Evaluation of New Products</li><li>Training and Development</li><li>Scientific Updates</li><li>Activities for Digital Platforms &amp; Other activities</li><li>Support Medical writing , Publication and communication</li></ul> Requirements: <ul><li>MD (Pharmacology/Medicine) / MBBS</li></ul> Experience: <ul><li>5-8 year in Medical Affairs -</li><li>Freshers with exceptional academic qualifications will be considered</li></ul> Skills: <ul><li>MS Office</li><li>Excellent written &amp; oral communication skills</li><li>Disease/Therapy Knowledge</li><li>Business Acumen</li><li>Excellent Relationship Building Skills</li><li>Broad Understanding of Medical Affairs&nbsp;</li><li>Confidence to interact with Internal &amp; External Stakeholders</li></ul>

Reponsibilities: Product Level Strategy <ul><li>Market data and internal financials</li><li>Strategy (gain share, hold share, rationalize volume, improve price, etc.)</li><li>Target share</li><li>Inventory targets based on market dynamics, product strategy, etc.</li><li>Provides input for Product Champions</li><li>Decision-making for Day-to-day Commercial Operations</li><li>Incorporate Product Strategies while leading/making the following decisions:</li><li>Order processing</li><li>ROFR responses</li><li>New business bids</li></ul> Rolling 12-month forecasts <ul><li>New Product Intel and Near-term Launch Evaluation &amp; Tracking</li><li>Maintain master database of future product pipeline information at the customer level.</li><li>Share with Portfolio as needed.</li><li>Assess the right frequency of pricing &amp; volume intel requirements</li><li>Interpret the accuracy of intel based on existing data points and those gathered via subscriber information (IQVIA, export data, etc.)</li><li>Rolling 12-month New Product Launch Prioritization and Planning</li></ul> Tracking results vs. business case on new launches <ul><li>Provide leadership for Product Management, Pricing/Contracts, Customer Service, Forecasting and Marketing</li><li>Identify/execute process improvements, including IT solutions</li><li>Manage all aspects of OTB strategies &amp; tactics (price, vol, production)</li><li>Improve UPS execution and shipping costs while analyzing other 3PLs</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor’s or master’s degree preferred</li><li>10 plus years related work experience in the pharmaceutical industry, preferably generics</li><li>Excellent computer skills, including data collection experience</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Industry/Customer recognition</li><li>Financial acumen</li></ul> Skills &amp; Abilities <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific (e.g. coaching, negotiation, calibration, technical writing etc.)</li><li>Interpersonal Skills - Focuses on solving conflict; Maintains confidentiality; works well in a collaborative environment</li><li>Adapts to changes; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes or unexpected events. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements (e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.)</li><li>General Office environment</li><li>Occasional Travel</li></ul>

Responsibilities: Distribution Operations <ul><li>Oversee all distribution operations for the warehouse, assuring timely accurate and cost-effective deliveries.</li><li>Direct cycle counting procedures to maintain accurate inventory.</li><li>Review all transportation billing for accuracy before sending to AP.</li><li>Execute contract customer shipments to ensure timely deliveries.</li><li>Maintain and administers all departmental policies, SOP’s and training.</li></ul> Compliance and Audit <ul><li>Ensure compliance with all safety and regulatory guidelines.</li><li>Maintain the warehouse, shipping/receiving areas and distribution center in audit ready condition including upholding a strict level of cleanliness.</li><li>Ensure that all documentation is up to date and easily accessible.</li><li>Maintain an on-going relationship with Supply Chain for inventory and shipments issues.</li><li>Must be current with all federal counterfeit drug regulations, E-pedigree state laws and ASN rules and regulations with the wholesalers.</li></ul> Cross-Functional Support <ul><li>Maintain training records for all colleagues in your organization and ensure 100% compliance to training guidelines.</li><li>Work with finance on a monthly basis to ensure all shipments and customer orders have been processed are resolved for months end.</li><li>Works closely with Quality and Regulatory on all related issues. anticipates in audits as needed.</li></ul> Requirements: Education &amp; Experience	 <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Minimum of a Bachelor’s Degree, preferably with a Business, Technical and /or Supply Chain focus.</li><li>Minimum of 8 years’ experience in Supply Chain Operations.</li><li>Project management experience preferred.</li><li>Experience with Six Sigma/Process excellence tools, training or certification.</li><li>Shipment of Hazardous Material transportation certification.</li><li>APIC’s certification preferred.</li><li>Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Knowledge of US and international transportation and distribution practices.</li><li>Knowledge of Code of Federal regulations Title 21 part 210 and 211, and DEA rules and regulations for distribution/storage/manufacture of controlled substances is a must.</li><li>Must have working knowledge of serial shipping container code (SSCC).</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Strong communication, collaboration, and organizational skills.</li><li>Results oriented - identifies issues and drives the decision process.</li><li>Ability to effectively challenge assumptions/decisions and support the minority viewpoint when needed.</li><li>Influence management – ability to work cross-functionally at all levels.</li><li>Creative innovation skills, excellent influencing skills, and strong design and visualization capability.</li><li>Deals well with conflict – negotiator, mediator.</li><li>Collaborates with team members on plans (and holds team members accountable).</li><li>Good problem-solving skills, sound judgment.</li><li>Take decisive action and deliver tangible results in a fast-paced cross-functional organization and highly competitive industry.</li></ul> Physical Requirements: <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Able to sit and stand for up to 8 hours.</li><li>Able to walk through production areas.</li><li>Able to lift up to 30 lbs.</li><li>Distribution Operations Oversee all distribution operations for the warehouse, assuring timely accurate and cost-effective deliveries.</li><li>Direct cycle counting procedures to maintain accurate inventory. Review all transportation billing for accuracy before sending to AP.</li><li>Execute contract customer shipments to ensure timely deliveries. Maintain and administers all departmental policies, SOP’s and training.</li><li>Compliance and Audit Ensure compliance with all safety and regulatory guidelines.</li><li>Maintain the warehouse, shipping/receiving areas and distribution center in audit ready condition including upholding a strict level of cleanliness.</li><li>Ensure that all documentation is up to date and easily accessible.</li><li>Maintain an on-going relationship with Supply Chain for inventory and shipments issues.</li><li>Must be current with all federal counterfeit drug regulations, E-pedigree state laws and ASN rules and regulations with the wholesalers.</li><li>Cross-Functional Support Maintain training records for all colleagues in your organization and ensure 100% compliance to training guidelines.</li><li>Work with finance on a monthly basis to ensure all shipments and customer orders have been processed are resolved for months end.</li><li>Works closely with Quality and Regulatory on all related issues. anticipates in audits as needed.</li></ul>

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li></ul>

Responsibilities: <ul><li>Work with stakeholders to help develop a culture of proactive security &amp; resiliency risk management across all company Philippines operations.</li><li>Proactively drive a metrics-based security risk management program throughout Philippines operations.</li><li>Collaborate with Global Trade Services, Global Logistics, EH&amp;S, IT, and regional team members at facilities to maintain appropriate security, crisis management, and business continuity requirements.&nbsp;</li><li>Lead security training and awareness efforts to protect personnel, operations and assets against security related risks.</li><li>Manage and maintain the Philippines supply chain security programs in which company currently benefits from or can participate in the future (e.g. C-TPAT or other similar programs).</li><li>Work with the Facilities &amp; company IS (company Information Solutions department responsible for IT systems) management team to drive performance improvements across existing</li><li>security programs (e.g. contract uniform security service providers, physical security systems, and supply chain service providers).</li><li>Identify improvement opportunities, communicate findings with the leadership team, and implement changes after receiving approvals.</li><li>Conduct investigations into allegations or suspicious activity under the direction and scope of the ERSM department.&nbsp;</li><li>Coordinate executive protection, special event, and travel security efforts in Philippines.</li><li>Liaise with local, regional, and national law enforcement.&nbsp;</li><li>Project manage special projects and coordinate awareness resources when required.</li><li>Ability to travel globally (estimated 20%) domestic &amp; some international.</li></ul> Requirements: <ul><li>7 years of confirmed experience in security and/or security risk management, with leadership/supervisory experience in the areas of programs, guard operations, and physical security.</li><li>Candidates with experience setting up and managing security systems and procedures at electronics manufacturing sites belonging to multinational corporations would be preferred.</li><li>Proven ability to proactively implement data-driven security risk management programs.&nbsp;</li><li>Knowledge of physical security systems, including design, operation and maintenance.&nbsp;</li><li>Experience developing procedural documents.</li><li>Knowledge and understanding of supply chain security methodology including requirements with the CTPAT program.</li><li>Demonstrated experience in crisis management and business continuity.&nbsp;</li><li>Experience and training in conducting investigations.</li><li>Ability to conduct training on various risk and security related topics</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: Product Testing: <ul><li>Demonstrate expert-level knowledge in fiber optic component and assembly testing.</li><li>Develop and optimize test specifications and methodologies for optical components and assemblies.</li><li>Design and implement complex tests using state-of-the-art equipment.</li><li>Create, review and estimate fiber optic test plans.</li><li>Lead the development of new sample preparation techniques and testing procedures, creating comprehensive documentation and training materials for the team.</li><li>Perform in-depth data analysis and interpretation, identifying trends, potential failures, and opportunities for product improvement.</li><li>Collaborate with cross-functional teams, including product development, quality assurance, and manufacturing, to ensure seamless integration of test results into the product lifecycle.</li><li>Lead multiple high-priority projects simultaneously.</li><li>Manage timelines, resources, and deliverables for various testing initiatives.</li><li>Maintain a safe, orderly, and efficient work environment in both office and laboratory areas, setting the standard for workplace organization and safety compliance.</li><li>Report project status to key stakeholders.</li><li>Drive innovation in test methodologies and equipment utilization.</li></ul> Lab Oversight: <ul><li>Oversee daily operations of the fiber optic test laboratory</li><li>Manage lab resources, including equipment, supplies, and budgets</li><li>Coordinate workload and assign projects to lab personnel</li><li>Ensure compliance with safety regulations and quality standards</li><li>Develop and implement lab policies and procedures</li><li>Participate in strategic planning for laboratory expansion and capability enhancement.</li><li>Identify opportunities for process improvement and cost reduction</li><li>Collaborate with other departments to align lab capabilities with company goals.</li></ul> Requirements: <ul><li>Bachelors or Master’s degree in Electrical Engineering, Optical Engineering, or related field</li><li>10+ years of progressive experience in fiber optic testing</li><li>Management or team lead experience a plus</li><li>Demonstrated expertise in fiber optic technologies and test methodologies</li><li>Strong background in data analysis, statistical methods, and test automation</li><li>Excellent leadership, communication, and interpersonal skills</li><li>Proven track record of technical leadership and project management</li><li>Experience in lab operations, resource management, and budgeting</li><li>Proficiency in MS Office Suite, test automation software, and data analysis tools</li><li>Adaptability to shifting priorities and ability to manage multiple projects</li></ul> Physical Demands: <ul><li>Must be able to lift up to 35 pounds without assistance</li><li>Capable of sitting for extended periods while performing detailed analytical work</li><li>Occasional standing, bending, and maneuvering in laboratory environments</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

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Staff Fiber Optic Test Engineer

Lead Quality Specialist - Investigator

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15 physical therapy Jobs found

Logistics Manager

Senior Manager Supply Chain

Medical Affairs Lead

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Facilities Security Manager

Quality Control Supervisor

Staff Fiber Optic Test Engineer

Lead Quality Specialist - Investigator

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.