Quality Manager

Operations Supervisor

Security & Emergency Assistant Manager – GL2

Facilities Security Manager

Quality Control Supervisor

Senior Quality Engineer

Analyst, Global Trade Compliance, GTS Automotive Business Unit

Lead Quality Specialist - Investigator

Manufacturing Engineering Molding Engineer

Key Responsibilities: <ul><li>Develop, document, implement, and manage the Quality Management System (QMS) for the sub-business unit.</li><li>Foster a Zero Defect Culture and deploy continuous improvement initiatives to enhance operational performance.</li><li>Utilize structured problem-solving techniques to identify root causes and implement corrective actions.</li><li>Serve as a Our client Operating Advantage Champion, driving quality improvement initiatives.</li><li>Implement and refine 1ADM/1CP Quality initiatives, ensuring consistency and efficiency across enterprise-wide procedures.</li><li>Interface with key customers to address concerns related to product and process quality.</li><li>Arrange for QC inspections of incoming and outgoing products and establish AQL procedures through DQIP plans and audits.</li><li>Manage customer complaints (RMAs), ensuring timely investigations, root cause analysis, and resolution.</li><li>Engage in ADM QPL Committee to uphold compliance with military specifications (Mil-Spec) for government agencies such as DLA and Nav-Air.</li><li>Build team capabilities by developing robust succession plans and talent pipelines.</li><li>Report directly to the our client Hauppauge Plant Manager with a dotted-line report to the Regional Senior Quality Manager.</li></ul> Requirements: Qualifications &amp; Experience <ul><li>Education: Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical/quality discipline.</li><li>A graduate degree is a plus.</li><li>Experience:</li><li>Minimum 8 years of quality management experience in a discrete manufacturing environment.</li><li>Experience in Aerospace products markets is a plus.</li><li>Minimum 5 years of global leadership experience is preferred.</li></ul> Skills &amp; Competencies: <ul><li>Strong understanding of our client ADM business unit and Relay &amp; Contactors Plant Groups.</li><li>Ability to operationalize strategies for the Global Quality organization.</li><li>Strong leadership abilities in building effective teams and aligning them with company mission and standards.</li><li>Exceptional problem-solving, analytical, and technical writing skills.</li><li>Excellent communication, planning, and time management skills.</li><li>Ability to work at all levels of the organization with influence and strategic insight</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>Promote security awareness program to instil a security culture and ensure a secure work environment.</li><li>Conduct regular assessments and audits to identify vulnerabilities and develop strategies to mitigate risks.&nbsp;</li><li>Provide briefing and guidance to ensure the outsourced security team always performs their duties effectively according to company security policy to meet the service agreement KPI.&nbsp;</li><li>Provide a monthly comprehensive report/update for management-related review.&nbsp;</li><li>Fully support internal Investigation for any security-related non-compliance incident. Prepare investigation reports to update the management. Including lodge police report if necessary</li><li>if there are cases related to the loss of the company’s properties or injury to site personnel.&nbsp;</li><li>Preparation of Investigations Report as well as evidence for Domestic Inquiry (DI) related cases.&nbsp;</li><li>Develop and maintain strong relationships with key stakeholders to ensure effective communication and collaboration.</li><li>Address stakeholders concerns and complaints promptly and professionally.&nbsp;</li><li>Support Facilities and Operations Team on contractor Management to ensure all contractors comply with EHS / Security / HR protocol and requirements.&nbsp;</li><li>Perform/Involved internal/external Audit/Risk Assessment</li><li>Conduct security standards briefing during new hire orientation.</li><li>Required to work in various areas throughout the building/site.&nbsp;</li><li>Continuous improvement in security processes and systems to ensure abreast with industry best practices and to support internal stakeholder needs.</li><li>Coordinate systematically outsourced security team &amp; sub-ordinates when responding to emergencies situations/alarms, Work Place Violence, Authorities’ Raids as well as assisting plant</li><li>Emergency Response Team (ERT)</li><li>Main support for plant ERT execution during emergencies. Work closely with EHS/ERT Commander to lead, control crowd and secure site during emergency.</li><li>Attend meetings, professional seminars such as TAPA FSR, Loss Prevention Skills, Security Technologies, or conferences to keep abreast of changes in executive legislative directives or new</li><li>technologies.</li><li>Work effectively on Integrated Security Systems such as CCTV, VMS, Access Control System, Emergency Door Alarm, Biometric System, Key Management, Boom Gates and Badging</li><li>System.</li><li>Develop with Security Induction Training for new hires, Refresher Training (Online) and create awareness on Security aspects by having proper email communication &amp; strategy.</li><li>Ensure Security ID Badge being issued timely with proper access granted.</li><li>Establish and maintain liaison with relevant government agencies (Police, Anti-Drug Agency &amp; Fire brigade Depts.) in District/State Levels for security and safety purposes.</li><li>To participate in the Plant Safety Committee, and all other committees and/or processes involving safety.</li><li>Drive K-Values.</li><li>Adhere to and administer company policies and procedures.</li><li>Other duties as assigned.</li></ul> Requirements: <ul><li>Bachelor or Diploma in science, economics or equivalent education with experience working as a Security Ops Manager &amp; Investigation lead more than 5 years.&nbsp;</li><li>Extensive knowledge of fire prevention, safety, and security operations.</li><li>Availability to respond to security alerts outside of business hours.</li><li>Conducts risk management audits and good skills in asset loss investigations.</li><li>Demonstrate organisational, communication, leadership and analytical skills.</li><li>Respond to medical emergencies, bomb threats, fire alarms, or intrusion alarms, following ERT activities.</li><li>A working knowledge of environmental, health and safety regulatory requirements.</li><li>Must strictly comply with the standards, policies and procedures outlined.</li><li>Effective computer skills with a working knowledge of MS Office and other related computer software packages.</li><li>Time management skills are needed to maintain deadlines for Corporate and regulatory reporting.</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: <ul><li>Develop and implement quality standards to meet Quality Management System to assure products meet or exceed customer expectations.</li><li>Lead cross-functional problem-solving teams; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation and monitoring of effective corrective and preventive actions</li><li>Performs routine supplier and plant audits to ensure product being manufactured meets all requirements.</li><li>Lead cross-functional teams to drive process and product improvements in manufacturing plants and at suppliers.</li><li>Work with Manufacturing, Engineering, and PM to determine product specifications and tolerances.</li><li>Participates in various NPI projects to ensure quality is incorporated into product designs and be responsible for preparing all quality-related documentation.</li><li>Support the development of FMEAs, Control Plans, Test and Inspection Plans.</li><li>Establish and maintain control plans to assure critical features are controlled through manufacturing processes.</li><li>Reviews and integrates contractual requirements into all aspects of proposals and program processes and documentation.</li><li>Conducts capability assessments and process validations to support supplier selection activities.</li><li>Provides material review dispositions for non-conforming materials or products.</li><li>Plan, execute, and oversee inspection and testing of products to verify conformance with specifications and deliverables.</li><li>Update company complaint handling system to ensure capture, investigation, and proper documentation of all customer complaints.</li><li>Manage documents related to ISO certification, procedures, standards, customer change requests, ECN, PCN, and/or Work Instructions.</li></ul> Requirements: <ul><li>Bachelor’s degree, Engineering or related technical discipline.</li><li>8+ years’ experience in Quality Engineer role in a production environment.</li><li>Familiarity with ISO 9001, AS9100 or ISO/TS 16949 QMS standards.</li><li>Experience in reading blueprints and have basic understanding of GD&amp;T fundamentals.</li><li>Experience effectively utilizing statistical methods and statistical analysis tools.</li><li>Experience with APQP, PPAP, FMEA, Control Plans, and various problem solving tools.</li><li>Experience in statistical tools and disciplined problem-solving methodologies such as 8D, A3, DMAIC, Fishbone,5-Whys, 6Ms.</li><li>Self-motivated, proactive and efficient team player who thrives in a fast-paced environment.</li><li>Able to travel 20% - 30% domestically and 10% internationally.</li><li>Must be eligible to work in the US with no sponsorship now or in the future.</li><li>Technical understanding of electrical power systems and electrical power distribution/circuit protection products.</li><li>Six Sigma Green, Black Belt, or comparable certification, preferred.</li><li>Excellent communication skills written, verbal, and presentation skills with effective technical writing skills, ability to speak Spanish is a plus.</li><li>High-energy, results-oriented, self-reliant, team player who can positively collaborate across different business departments and cultures.</li><li>Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook)</li><li>Experience in the electrical-mechanical manufacturing or solar industry.</li><li>Experience in conducting supplier and plant audits.</li><li>Experience in reviewing customer contracts.</li></ul>

Responsibilities: Trade Compliance Activities in the BU in China: <ul><li>Manage trade operations and provide compliance oversight for the assigned BU to ensure company compliance with import/export laws and regulations.</li><li>Establish and maintain trade operations and compliance activities in accordance with company policies, procedures, and controls, in collaboration with key stakeholders throughout the</li></ul> BU. <ul><li>Act as a point of contact for BU leadership on trade-related matters.</li><li>Engage BU stakeholders and counsel to understand business changes and develop trade-related solutions/strategies and controls to ensure compliance.</li><li>Maintain BU-level Key Performance Indicators (KPIs) and reporting to ensure efficiency and effectiveness of the operations.</li><li>In partnership with GTS Governance, establish and maintain relationships with trade-related government entities.</li><li>Collaborate with GTS AUT BU leader to carry out different trade compliance initiatives and projects in China.</li><li>Serve as subject matter expert on China trade activities, including but not limited to bonded e Book management and reconciliation, FTZ operation, FTA program, classification, country of origin determination and valuation and customs audits, investigations and inquires.</li><li>Advises on businesses with trade related compliance risks and issues, such as sanctions, export control, supply chain optimization or other China specific regulatory matters.</li><li>Act as the first point of contact for local customs authorities, for managing customs audits, investigations and inquires, and develop corrective action plans.</li><li>Lead continuous improvement of trade compliance Conduct trade compliance trainings for AUT China plants. and Imp/Exp.&nbsp;</li><li>Related policies and processes in AUT China.</li><li>Lead GTS AUT China team to ensure compliance and efficiency of AUT China Imp/Exp and trade operations.</li></ul> Partner with Trade Compliance Professionals and Stakeholders across the Enterprise: <ul><li>Partner with GTS Governance to monitor trade compliance regulatory and legislative changes, assess the potential impact to the BU, and determine the necessary actions and communications to the appropriate stakeholders.</li><li>Work with GTS Governance teams to conduct trade compliance audits and oversee corrective action plans.</li><li>Partner with GTS Governance to develop and administer effective trade compliance training as required throughout the region and organization.</li><li>Ensure appropriate utilization of the GTS Operations Service Center for product classification (import and export), restricted party screening, and duty savings compliance, and otherwise ensure proper country of origin determination, valuation, and admissibility.</li><li>Work with the Operational Service Centers enters to identify, evaluate and administer opportunities to facilitate trade in a cost-effective and compliant manner (e.g. make use of applicable Free Trade Agreements, Duty Drawback, First Sale for Export, Foreign Trade Zones, etc.)&nbsp;</li><li>Establish and maintain relationships with internal functions, including corporate functions, to encourage awareness of global trade compliance issues, pro-actively identify trade risk and threats, and develop appropriate trade compliance controls.</li><li>Build strong relationships with relevant business functions, such as supply chain team or logistics team to support business and carry out different trade compliance initiatives and projects in plant operation.</li></ul> Talent Development &amp; Leadership: <ul><li>Create a culture of engagement and performance in alignment with company core values.</li><li>Provide timely, thoughtful feedback to support your team’s growth and development.</li><li>Lead by example and act with empathy.</li></ul> Requirements: <ul><li>Strong knowledge of China Imp/Exp and Customs laws and regulations.</li><li>Strong foundational knowledge in trade compliance areas.</li><li>Superb knowledge and management capability in China bonded manufacturing mode.</li><li>Bachelors degree required (international business, supply chain, law, or related field).</li><li>8+ years’ experience in global trade compliance.</li><li>Preferred: 3+ years’ experience in functional leadership or senior management in a multinational environment.</li><li>Preferred: 3+ years’ experience in supporting trade functions within an industrial, communications, transportation, or similar business.</li><li>Broad functional knowledge of import and export regulations and familiarity with customs practices in countries across the region.</li><li>Proven ability to work with variety of business groups, including supply chain, legal, procurement and finance.</li><li>Ability to foster teamwork and internal and external relationships.</li><li>Excellent organizational habits and priority management.</li><li>Customer focused with a commitment to quality.</li><li>Preferred: Customs Broker License other Customs / Trade certification.</li><li>Travel may be necessary in fulfilment of responsibilities.</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>

Responsibilities: <ul><li>Responsible for Molding Process, Tool Design development, (New &amp; Old tools) Qualification and Trial</li><li>Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout</li><li>Participate and engage on product development, Tool Design, DFMEA / PFMEA</li><li>Work with Global COE Assembly to drive continuous improvement in Molding Technology / Process</li><li>Maintain proper documentation and for all Mold tooling, Spares, Mold and Process Set-up Sheets</li><li>Ensure all Tooling / Mold design drawings (Soft &amp; Hard Copy) are up to date.</li><li>Impart trainings and development for new joiners, Technical Trainees etc</li><li>Multi skilling among, Stamping tool design and Mould tool design&nbsp;</li><li>Coordinating with inter-department and assists with investigations of reject product and the development of corrective actions.</li><li>Drive company OA culture in shop floor.</li><li>Coordinate with Manufacturing Engineer for new product development and process improvement.</li><li>Assessing resource requirements and opportunity for Automation and Process Productivity improvement</li><li>Review of company OA deployment</li><li>Review ISO documents and update</li><li>Engage in ISO audits</li><li>Visit vendors for Assembly tooling assessment (Capability, Know How &amp; Capacity)</li></ul> Requirements: <ul><li>Bachelor in Mechanical Engineering major or Industrial Engineering</li><li>3-5+ years’ experience and practitioner in the Tooling Design &amp; Development</li><li>CAD Knowledge Must, preferably Pro E / Creo &amp; Auto-cad, Solidworks, NX, etc.</li><li>DFM analysis, New Mold / Tooling RFQ</li><li>Stamping Tool Debugging</li><li>Computer Knowledge, MS Office etc, SAP knowledge added advantage</li><li>Tool Room Process’s</li><li>Tooling Knowledge</li><li>Know How on core competencies (Stamping, Tool Design, Auto- Assy is an added advantage)</li></ul>

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12 remedial investigations Jobs found

Quality Manager

Operations Supervisor

Security & Emergency Assistant Manager – GL2

Facilities Security Manager

Quality Control Supervisor

Senior Quality Engineer

Senior Quality Engineer

Analyst, Global Trade Compliance, GTS Automotive Business Unit

Lead Quality Specialist - Investigator

Manufacturing Engineering Molding Engineer

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12 remedial investigations Jobs found

Quality Manager

Operations Supervisor

Security & Emergency Assistant Manager – GL2

Facilities Security Manager

Quality Control Supervisor

Senior Quality Engineer

Senior Quality Engineer

Analyst, Global Trade Compliance, GTS Automotive Business Unit

Lead Quality Specialist - Investigator

Manufacturing Engineering Molding Engineer

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