QA - Compliance Specialist in Madison at Apple & Associates

Date Posted: 5/15/2018

Job Snapshot

Job Description

Our client is a leader in the biopharmaceutical industry.  They are in need of a QA Compliance Specialist for their R&D program.
 
Responsibilities:
  • Assists in developing, implementing and maintaining a specialized quality system to support the R&D programs including quality assurance for GMP and GLP supplies.
  • Oversee and coordinates investigations, provides direction and guidance for investigations and executes them when needed.
  • Provide Quality Systems support for complex technical projects and in troubleshooting activities.
  • Assist with Contract Development and Manufacturing (CDMO) and product technical transfers to commercial state.
  • Assist in building, maintaining and continuously improving a specialized quality system to support R&D and CDMO programs.
  • Ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production and record review and retention.
  • Answers customer communications and helps build a customer support program.
  • Reviews completed batch records for completeness, accuracy and compliance to process parameters.
  • Actively participates as quality support to R&D and the manufacturing departments that is performing the technical transfer.
  • Completes Deviations and Corrective Action / Preventive Action (CAPAs) as needed.
  • Perform internal audits
  • Serve as right hand person to Quality Manager
Requirements:
  • Bachelor's Degree in Chemistry or related field.
  • 4+ years of similar experience in the pharmaceutical / biopharmaceutical / medical device industry (FDA regulated industry).
  • Experience with GMP, GLP, cGMP, and SOPs.
  • Strong investigation handling through all stages including deviations and CAPAs
The company offers a comprehensive benefits package including:
  • Very competitive salary based upon experience
  • Health, dental, life and disability insurance
  • Bonus program
  • 401K with match
  • Paid vacation and holidays
  • Tuition reimbursement
Jump start your career and apply now!  We review all resumes and applications submitted.  A staff member will contact you directly if you meet the qualifications for the position.  No visa sponsorship or relocation assistance is available.

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