Quality Assurance Lead

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

ADA Accommodation Notice
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
Physical Requirements
• Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.
• Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE).
• Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
• Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures.