Quality Assurance Lead (3rd Shift)

Responsibilities

• Implement, coordinate, administer, and continuously improve the Quality Assurance AQL Visual Inspection / On-The-Floor program:
• Responsible for development and quality oversight of the visual inspection /quality on the floor program.
• Partners with manufacturing and other internal groups to establish a philosophy for visual inspection and develops the visual inspection qualification for operators and QA AQL Specialists.
• Builds and maintains qualification kits.
• Collaborates with manufacturing to develop the program for classification of rejects and AQL levels.
• Participates in equipment design and start-up of automated equipment and manual/semi-manual visual inspection start up.
• Supports implementation / qualification of automated inspection procedures.
• Reviews all SOPs, policies, work instructions, batch records, etc. regarding visual inspection, defects, rejects, and defect kits.
• Develops QA documents for visual inspection AQL inspection.
• Quality reviewer/approver for visual inspection deviations, change controls, CAPAs, etc.
• Completes training and maintains required qualifications for visual inspections.
• Responsible for performing QA line clearance for visual inspection and audits of the fill/finish area.
• Analyzes and trends AQL defects, provides metrics, and presents KPIs.
• Reviews and approves process generated data from manufacturing visual inspection.
• Ensure regular presence in operational areas and support personnel on quality matters.
• Real-time batch record reviews and in-process auditing.
• Routine walk-throughs of production areas, laboratories, and warehouse to ensure inspection readiness of the facility. Routinely communicate findings and ensure issues are corrected in a timely manner.
• Ensures processes are executed according to batch records and procedures. Ensures any potential compliance issues identified during batch record review are corrected and clarified.
• Provides constructive feedback to individuals executing batch records and communicates best practices to share with different areas of manufacturing.
• Collaborates with planning groups to prioritize critical lot disposition. Also ensures that the schedule is being monitored and operations has all the required releases to ensure no downtime.
• Identifies process improvements of batch record review and product disposition processes.
• Oversees labeling activities, verifies labeling issued to and returned from operations.
• Immediately escalates issues to QA management, submits event notifications where appropriate.
• Ability to assess and triage deviations that occur with the local process team. Write, review, and assess deviations, and participate in investigations. Support CAPAs, gap analysis, and product complaints.
• Develops strategy on how to achieve the work that needs to be completed, works with manufacturing to determine schedule and support. Ensures appropriate coverage which may include some evenings.
• Provide support during internal / external / regulatory inspections.
• Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.
• Communicate clearly with cross-functional teams.
• Train and qualify future QA AQL Specialists
• Other duties as assigned

Requirements

• Bachelor’s degree in science or other related discipline, or equivalent level of skill and experience
• A minimum of 4 years of AQL inspection experience in the pharmaceutical industry with liquid and lyophilized products
• Quality Engineer Certification preferred
• Highly organized individual with strong attention to detail
• Ability to management time and priorities effectively

Physical Requirements

Additional information