My name is Crystal Valdez and I represent The Fountain Group. We are a national staffing firm and are currently seeking a QA Specialist Drug Product for a prominent client of ours. This position is located in Fremont, CA. Details for the position are as follows:
- Responsible for the tactical execution of quality assurance oversight activities of the assigned area which may include oversight of any area of the business responsible for adhering to current good manufacturing practices (cGMPs) including warehouse, manufacturing processes, inspection, batch record review, batch disposition, new product introduction/product transfer, and QC laboratories.
- This includes timely identification of events impacting the Quality of products and processes evaluate situation for potential impact, work with junior staff to assess the event, and notify appropriate senior staff or management for further assessment as needed.
- QA oversight responsibilities include creating and/or revising SOPs, ensuring adherence to SOPs and requirements, proper change management, supporting corrective action and preventive action plans (CAPA)/Deviation management, and to ensure documentation and/or investigations and regulatory standards.
- Oversight is assured through close attention to activity execution close to the assigned area and mentoring of junior staff including consistent support (i.e., Cell Culture, Purification, Formulations, Filling, other Technical Areas, Laboratories, etc.) This also includes identification of potential continuous improvement ideas.
- Provides strong quality oversight and consultation to ensure compliance with cGMP's, regulatory, industry, and corporate requirements.
- This position will primarily support Drug Product, Packaging, and Logistics areas.
- Minimum of intermediate knowledge of relevant regulations and guidances. (i.e. cGMPs, SOPs, Protocols).
- In lieu of a Bachelor's Degree, a High School Diploma will be considered with a minimum of two (2) years quality pharmaceutical industry experience with cGMPs in areas described in this profile.