GMP Compliance Associate
1 week ago
About PrideStaff: PrideStaff is a national staffing organization delivering innovative solutions to the challenges employers face every day. We've been a consistent industry leader, developing technology and service processes that allow us to deliver superior performance. With locations across the United States, we're well-positioned to partner with clients and candidates to ensure a successful match of employee talent with customer needs.
GMP Compliance Associate Job Description: This is an excellent opportunity for a skilled GMP Compliance Associate to join our team in Carlsbad, CA. As a member of our Quality Control department, you will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) regulations and guidelines. Your key responsibilities will include executing incoming inspection of raw materials, conducting environmental monitoring, and assisting in the expedition of test sample shipment to sponsors and 3rd party laboratories.
Responsibilities:
- Execute incoming inspection of raw materials in accordance with company policy and procedures
- Conduct environmental monitoring for the facility on a routine basis per applicable SOPs including sampling of the USP Purified Water system and associated plant utilities
- Assist in the expedition of test sample shipment to sponsors and 3rd party laboratories
- Execute deviation/OOS investigations and implement CAPAs and change controls per GMP requirements, as needed
- Assist in the execution of analytical method transfer activities, including product-specific test methods
- Directly contributes to daily laboratory operations for QC Chemistry and Microbiology, in full compliance with applicable SOPs and safety guidelines
- Analyzes on a routine basis in-process, release, and stability test samples in accordance with established QC test methods and specifications
- Assumes the role of safety liaison with EHS and Safety Officer
- Assists QA in calibration/preventive maintenance activities associated with lab instrumentation
Requirements:
- Undergraduate degree (B.A. or B.S.) in a Life Science discipline
- 3-4 years' GMP experience in a Quality Control function within the medical device and/or biopharmaceutical fields
- Direct experience with EM sampling and aseptic technique
- The ability to perform daily tasks with a keen attention to detail
- An affinity for precise and detailed documentation skills
- The ability to work effectively and contribute to a dynamic and fast-paced work environment
- Well-developed oral communication and listening skills
- Applicable academic or industrial laboratory experience
- High-level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
Estimated Salary: $33-$45/hour DOE
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