North Carolina All, North Carolina
- This position provides Quality Assurance oversight of Manufacturing and Quality Control areas.
- Provides QA review and approval of new and existing procedures, investigation/deviation documentation, and process control/validation documents.
- Uses trend and investigational data to create value through process improvements and failure reduction activities.
- The incumbent must act independently to identify failure modes and related process improvements, facilitating teams and working independently to implement required changes.
- Performs QA technical review for assigned area.
- Provides final QA approval on all quality events, deviations, laboratory investigations, complaint investigations, corrective/preventative actions, effectiveness checks, and compendial assessments. May also provide QA approval on change controls or other documents associated within the business unit.
- Provides first response for Quality and Compliance issues on the manufacturing floor and the laboratories.
- Provides review and QA approval of: Deviations, Laboratory Investigations (OOS/OOT/OOE), and other Quality Events; Quality Assurance Protocols/Reports; Change Documentation (CCR s, etc.); SOPs; Electronic builds of Master Batch and Packaging Records (MES); Compendial Assessments
- May also review and approve validation documents as well as QC Methods and Specifications
- Uses data trends to work with operating departments to identify process improvement opportunities.
- Participates and/or Leads triage activities for quality events
- Drives compliance, efficiency, or process improvement projects.
- Represents QA on cross functional improvement and process monitoring teams.
- Leads and/or participates in scheduled and unscheduled internal audits of operational areas and laboratory areas.
- Assists in In-Process Quality Assurance (IPQA) functions, such as first response for Quality and Compliance issues, line clearance checks, etc.
- Interacts closely with Quality Systems, Operations, Manufacturing Science & Technology, Supply Chain, and Lab Management to ensure unfavorable trends are identified and resolved
- May provide QA representation on Raw Material Issues team ensuring information continuity for incoming quality concerns through Supply Chain to vendors.
- Reports metrics weekly, monthly, KQI, Quality Council, etc. Provides deviation/investigation data and summaries for Annual Product Reviews (APRs). May also lead or participate on teams for tracking of quality activities, metrics, CAPA tracking, etc.
- Receives little supervision for most assignments. Receives general instructions for non-standard analyses and projects. Data analysis is complex and requires input from multiple sources and innovative problem-solving. Interfaces to negotiate and exchange information with all levels of management.
Work Experience: Experience in a GMP laboratory and/or production environment.
Certifications: ASQ CQE/CQA a plus.
Lifting: Infrequently lifting 25kg to waist height.
Approx 25% on floor time (Walking/Standing).
Limited Travel (1-5 times/yr.).
Other Qualifications: (i. e. skills, knowledge) Knowledge of applicable processes, validation, investigation review. Proven ability to work in a team environment through conflict resolution and negotiations. Fundamental understanding of applied statistics. Excellent written and verbal communication skills.
Education: BS/BA in Chemistry, Engineering or life sciences and a minimum of 5 years of professional pharmaceutical-related experience