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Job Details

QA - Compliance Specialist

Company name
Apple & Associates, Inc.


Madison, WI
3 hit(s)  


Job ID


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.

Company Profile
At Apple & Associates, we understand that relationships are what make us stand apart. Whether you are a client or a candidate, you are an extension of the Apple & Associates’ family. Many of our recruiters have been with the company since its earliest days. They take great pride in the relationships they build; always emphasizing high standards, ethics and quality service. Our President, Debi Apple started her recruiting career in Aiken, South Carolina. She quickly became a top producer and leading authority in recruiting for the medical device, pharmaceutical and consumer product industries. Her passion and drive led her to open Apple & Associates in 1993. Under her leadership, Apple & Associates has grown to be one of the leading recruiting firms in these industries. Our company is proud to represent two of the largest medical device and pharmaceutical companies in the U.S., Covidien (formerly known as Tyco Healthcare) and our first and longtime client, Becton Dickinson. Now headquartered in Chapin, South Carolina, Apple & Associates has offices from coast to coast, offering regional recruiting expertise throughout the U.S. and Latin America. Our searches and permanent placements represent all levels, from CEO to staff level positions.

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