QA Auditor & Compliance Specialist

Published: September 5, 2017
Job Type
Education Required
Knowledge of science generally attained through studies resulting in a B.S. in microbiology, biology, biotechnology, or related discipline.

Description

Requisition No.: 21798-1

Status: Full Time

Project Duration: 6 months

Position Description:

To provide operations with the appropriate service and advice to assure that manufacturing activities are carried out within the framework of corporate/governmental policies and regulations (cGMP’s) and; to assure that site quality systems are in place for regulatory compliance. the incumbent works with minimum supervision. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

  1. Completes investigations for returned goods, damaged goods, process deviations and laboratory investigations.
  2. Recommends material or product disposition, if required.
  3. Prepares annual product reviews report for each bulk drug substance and pharmaceutical finished product.
  4. Recommends our regulatory section to handle and update documentation intended for regulatory agencies (i.e. FDA), such as master files, new product registration, supplement submissions, foreign countries registrations, etc.
  5. Reviews, evaluates and approves plant operating documents, such as SOP’s, master batch records, manufacturing change control and process deviations. Maintains documents in an organized and traceable manner.
  6. Evaluates specification, recommends and submits changes when necessary to the specifications committee.
  7. Provides escort/assistance in managing all aspects of regulatory and corporate inspections (FDA, EMEA, etc.).
  8. Recommends lots for stability submission.
  9. Ensures compliance of all procedures (SOP’s) to avoid regulatory issues.
  10. Provides advice and service to all operating departments as to assure compliance with cGMP’s and other regulations. (This includes frequent feedback on performance regarding deviations, rejections, complaints, outstanding commitments, trends, etc.)
  11. Investigates customer complaints, issues the corresponding report indicating possible cause and recommending solutions.
  12. Conducts and documents GMP and/or SOP’s training as required.
  13. Completes investigation of material for rejection.
  14. Performs formal internal audits and pre-approval inspections of manufacturing, laboratory and warehouse operations for cGMP’s compliance. Regularly reports as necessary and follows up on observed deficiencies.
  15. Evaluates inventory frequently to drive closure of pending items to assure timely disposition.
  16. Assists in the Supplier Qualification/Certification program.
  17. Performs readiness exercises for government inspections.
  18. Assists in the review of manufacturing records and assign material disposition when required.

Skills Required

• Knowledge of US, EU and cGMP regulations and guidance is required.
• Knowledge and experience with electronic systems such as Trackwise®, MS Word, PowerPoint, electronic document management system and Excel is preferred for this position.
• This position exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Coordinates with higher level quality leads on decisions and applies appropriate notification to management as needed.
• Requires excellent communication skills and the ability to work in a team based environment and interact well with other employees at various levels.
• Personnel must demonstrate strong organizational skills, flexibility and have the capability to handle several high priority items simultaneously on an ongoing basis.
• Supervisory attention will be determined based on demonstrated capabilities.

Skills Preferred

• CAPA's, Trackwise, and Pharma especially desired.

Experience Required

• A minimum of 4-6 years of relevant experience in a bio-pharmaceutical / biotechnology regulated environment with at least 2 years focused in a quality assurance or regulatory compliance area.
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