Manufacturing Quality Assurance Specialist II - Third Shift

Kindeva Drug Delivery-posted 4 months ago
Lexington, KY
1,001-5,000 employees
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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 any 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 but not limited to real time auditing of production batch records, sampling and AQLS, line clearances.
  • Supports the development and maintenance of Quality Systems as appropriate.
  • 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.
  • Evaluates proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards.
  • Participates in investigations and root cause analyses for deviations, OOS results, and audit findings.
  • Ensures timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
  • Reviews, and approves cGMP documentation including but not limited to 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.
  • Performs activities associated with various one-time or on-going projects (from participation level to project manager).
  • Collaborates with departments and external suppliers regarding quality concerns.
  • Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
  • Supports regulatory inspections and customer audits.
  • Assists Manager with daily and project activities as needed.
  • Other duties as assigned.
  • Bachelor degree in a scientific discipline
  • At least 7 years 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, to identify solutions, to plan and implement necessary changes
  • Experience in quality systems auditing (internal and/or external) preferred
  • Familiarity with electronic QMS platforms (e.g., TrackWise, MasterControl, etc.)
  • Experience in manufacturing aseptically filled, sterile products preferred
  • Advanced knowledge of cGMP regulations and validation principles (e.g. 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.
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