QA Specialist Drug Product
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a QA Specialist Drug Product to be part of our client’ s team in the East Bay. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
QA Specialist Drug Product
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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 meet BIFI 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.
- Bachelor' s Degree in Life Sciences OR
- 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.
- Minimum of intermediate knowledge of relevant regulations and guidance. (i.e. cGMPs, SOPs, Protocols).
- Strong attention to detail, interpersonal skills including conflict resolution/negotiation, organizational/time management skills, verbal/written communication skills, ability to work in a team environment, effective problem-solving, and ability to identify and escalate issues when necessary.