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Job Details

Quality Assurance Compliance Specialist

Company name
Markent Personnel Inc

Location
Madison, WI

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Quality Assurance Compliance Specialist

Markent Personnel

Madison

WI

Job #684941789

Quality Assurance Compliance SpecialistOur 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.

Updated 06/13/2018

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Company info

Markent Personnel Inc
Website : http://www.markentpersonnel.com/

Company Profile
We are a technical recruiting firm specializing in direct and contract placements with Upper Midwest companies. Our areas of expertise include: Engineering, Manufacturing, Management, Food, Quality, Purchasing, Information Services/Technology, Human Resources, Medical Devices and Technical Sales/Marketing.

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