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Quality Assurance GMP Specialist - Full-time / Part-time
| Hours | Full-time, Part-time |
|---|---|
| Location | Fort Collins, Colorado 80521 Fort Collins, Colorado |
About this job
Aerotek is currently hiring for a Quality Assurance GMP Specialist for a great pharmaceutical company in Fort Collins, CO!
Qualifications:
- Bachelor degree in a science related field
- Strong working knowledge in a GMP/FDA regulated facility
- Previous pharmaceutical experience (8+ years)
Job Description:
- Support R&D Projects and Programs that are in development by providing guidance based on relevant regulations and internal processes and procedures
- Review of CMC program protocols/, development reports and provide timely builds to R&D QA Manager and appropriate Project lead
- Position provides back-up support for R&D QA Manager for drug product disposition, SOP and relevant document approvals, as required
- Lead Quality review meetings where true root cause is determined and manage the timely closure of Quality events resulting from manufacturing and testing operations.
- Prepare Quality Technical Agreements for raw material and component suppliers and applicable testing laboratories
- Identify risk areas and provide recommendations on remedial actions that may impact product development
- Provide guidance and input on appropriate corrective actions to ensure continuous improvements in process capabilities
- Lead or participate in internal audits involving R&D CMC and Regulatory systems
- Ensure timely issuance of reports, evaluate and track audit responses
Please reach out to Paige if you are interested in hearing more (303) 876-6870.
About Aerotek:
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
Aerotek is acting as an Employment Agency in relation to this vacancy.