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Quality Assurance Auditor & Compliance Specialist

Townsend & Associates • Pennington, NJ

Posted 28 days ago

Job Snapshot

Contractor
Travel - None
Experience - 4 to 6 years
Degree - 4 Year Degree
Competitive salary based on experience
Chemical, Pharmaceutical, Other Great Industries
QA - Quality Control, Pharmaceutical, Other
Relocation - No
170

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Job Description

Quality Assurance Auditor & Compliance Specialist


Responsibilities:

 

  • 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)
  • Assure that site quality systems are in place for regulatory compliance.
  • Works with minimum supervision.
  • Must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
  • Completes investigations for returned goods, damaged goods, process deviations and laboratory investigations.
  • Recommends material or product disposition, if required.
  • Prepares annual product reviews report for each bulk drug substance and pharmaceutical finished product.
  • 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.
  • 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.
  • Evaluates specification, recommends and submits changes when necessary to the specifications committee.
  • Provides escort/assistance in managing all aspects of regulatory and corporate inspections (FDA, EMEA, etc.).
  • Recommends lots for stability submission.
  • Ensures compliance of all procedures (SOP’s) to avoid regulatory issues.
  • 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.)
  • Investigates customer complaints, issues the corresponding report indicating possible cause and recommending solutions.
  • Conducts and documents GMP and/or SOP’s training as required.
  • Completes investigation of material for rejection.
  • 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.
  • Evaluates inventory frequently to drive closure of pending items to assure timely disposition.
  • Assists in the Supplier Qualification/Certification program.
  • Performs readiness exercises for government inspections.
  • 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.
  • Assists in the review of manufacturing records and assign material disposition when required.


Quality Assurance Auditor & Compliance Specialist




Job Requirements

Quality Assurance Auditor & Compliance Specialist

W2 ONLY!!! 


Qualifications:

  • Knowledge of science generally attained through studies resulting in a B.S. in microbiology, biology, biotechnology, or related discipline.
  • 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.
  • 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.




Quality Assurance Auditor & Compliance Specialist

Job ID: 17-00520
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