Manufacturing Quality Assurance Specialist II - 2nd Shift

Manufacturing Quality Assurance Specialist II - 2nd Shift

Lexington, KY, USA

Responsible for on-shift support of manufacturing operations providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing, and testing. Also responsible for review of controlled cGMP documentation and manufacturing records including deviations or OOS that may have occurred during lot production. Participates during the release of raw materials, intermediates, and final products. Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues.

• Supports on-shift manufacturing operations and activities including real-time auditing of production batch records, sampling and AQL, line clearances.
• Supports the development and maintenance of Quality Systems as appropriate.
• Leads onboarding and training efforts for new QA specialists, manufacturing personnel, and support staff, ensuring consistent knowledge transfer and alignment with site procedures.
• Communicates complex quality concepts clearly to accelerate team readiness and performance.
• Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
• Advises senior management on findings and recommendations related to internal and external auditing.
• Manages deviation, OOS, CAPA and Change Control Systems
  • Evaluate proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards.
  • Serve as a key resource for deviation investigations, documentation, and CAPA development, applying strong analytical skills and root cause analysis to support compliance and audit readiness.
  • Ensure timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
• Reviews and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
• Develops and maintains metrics and trending reports for compliance-related activities.
• Reviews and approves product complaint investigations and assists with investigations.
• Participates and/or coordinates compliance assessments of departments (GXP, Part 11, etc.) as necessary.
• Supports regulatory inspections and customer audits.
• Supports quality-related inventory functions in Enterprise Resource Planning software (D365, JDE, etc.).
• Supports client communications via in-person or digital meetings, email, and other communication platforms.
• Assists manager/supervisor with daily and project activities as needed
  • Coordinate QA coverage and mentor team members across QA and manufacturing.
  • Represent QA in daily tier meetings, providing visibility into batch-related deviations and record review.
  • Fill in for QA management during senior management team meetings, engaging with cross-functional leadership to drive site-level improvements.
  • Participate in employee interviews, contributing to hiring decisions across departments.
• Other duties as assigned.

• Bachelor’s degree in a scientific discipline (preferred experience may be substituted for education).
• At least 3+ years of pharmaceutical/medical device cGMP quality experience.
• Knowledge of data integrity principles (ALCOA+) and compliance with 21 CFR Part 11 for electronic records.
• Knowledge of HPLC principles and ability to review data for accuracy and completeness.
• Knowledge of microbiological testing principles and ability to review data for accuracy and completeness.
• Ability to assess problems, identify solutions, plan and implement necessary changes.
• Experience in quality systems auditing (internal and/or external) preferred.
• Familiarity with electronic QMS platforms (e.g., Track Wise, Master Control, etc.).
• Experience in manufacturing aseptically filled, sterile products preferred.
• Advanced knowledge of cGMP regulations and validation principles (FDA 21 CFR Part 820, ISO 13485, etc.).
• Ability to work well in a team-oriented environment.
• Well-developed communication and technical writing skills.
• Qualified to work with controlled substances.
• Experienced in leading and assisting in deviation investigations and implementation of appropriate CAPAs.
• Physical requirements:
  
  regularly handle materials and supplies, use computers for extended periods, use telephone and electronic communication, stand and walk for extended periods, occasionally lift or move up to 25 pounds, use proper lifting techniques, follow all site safety procedures.