Operations Supervisor

Security & Emergency Assistant Manager – GL2

Quality Control Supervisor

Senior Quality Engineer

Lead Quality Specialist - Investigator

Customer Care Manager

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>

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>

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>Analyse the technical complaints of the vehicle in the field visits.</li><li>Rectify defects in vehicles / overhaul aggregates.</li><li>Maintain and handle internet-based warranty.</li><li>Ensure implementation of service processes at channel partners.</li><li>Joint Investigation along with vendors.</li><li>Development of secondary channel.</li><li>Feedback on companies as well as competitors’ products.</li><li>Training of service managers.</li><li>Work out special service support for strategic customers with channel partners.</li><li>Ensure execution of spare parts order by all channel partners for sufficient inventory and for meeting spare parts target.</li><li>Secondary network for spare parts sales.</li><li>Guide channel partners for manpower/facilities/equipment optimisation.</li><li>Ensure profitability of workshops of channel partners.</li><li>MIS on service.</li><li>Spare parts inventory management.</li><li>Manging service guarantee at the dealership.</li><li>Monthly visit to ASC and monitor his performance along with ASC coordinator.</li><li>Service camps on monthly basics.</li><li>Monthly visits to customer and update M Response data</li></ul> Requirements: <ul><li>Technical knowledge of BS6 Products</li><li>Exp. in Commercial Vehicle Segment</li><li>Exp. in Dealership Management/Field Service Management</li></ul>

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6 investigation Jobs found

Operations Supervisor

Security & Emergency Assistant Manager – GL2

Quality Control Supervisor

Senior Quality Engineer

Lead Quality Specialist - Investigator

Customer Care Manager

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6 investigation Jobs found

Operations Supervisor

Security & Emergency Assistant Manager – GL2

Quality Control Supervisor

Senior Quality Engineer

Lead Quality Specialist - Investigator

Customer Care Manager

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

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