Senior Quality Control Associate
300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a Senior Quality Control Associate to be part of our client’ s team in the North Bay. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
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.
Senior Quality Control Associate
- 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:
- This position will assist with the management of QC contract testing and cell bank production related activities. Key responsibilities may include:
- Provide support in organizing QC contract testing and cell bank production activities.
- Provide support in coordination of international shipments.
- Liaise between contract laboratories and internal groups.
- Assist with management of in-country testing and provide updates to team and management.
- Establish effective communication and collaborative relationships with other functional groups, key stakeholders, and external contacts.
- Maintain tracking spreadsheets/databases for contract testing lab activities and information.
- Organize and track contract testing and cell bank testing/production activities.
- May generate and/or revise Quality Technical Agreements with contract testing labs and contract cell bank manufacturers.
- Generate legal contract requests and purchase orders for contract testing and cell bank testing/production.
- Initiate change requests (CR) for new cell bank production and SOP revisions using TrackWise system.
- Perform log-based cell bank inventories.
- Request and coordinate cell bank vial shipments to/from offsite bio-repository.
- Assist with shipment of samples and reagents to contract labs.
- Manage and maintain good relationships with contract testing lab partners.
- Support regulatory filings.
- Support regulatory agency, partner and QP inspections.
Summary of Qualifications:
- B.S./B.A. degree with 4 years of experience in pharmaceutical industry, including some work in a laboratory setting.
- At least 4 years in a cGMP laboratory; quality control experience required.
- Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
- Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
- Experience in dealing with contract testing laboratories is highly preferred.
- Well-developed laboratory skills for analysis of pharmaceuticals and bio-pharmaceuticals.
- Demonstrated ability to perform most tasks with minimal supervision given general instructions on routine work and detailed instructions on new assignments.
- Proficiency in MS Applications.
- Excellent written and verbal communication skills
- Excellent organizational and project management skills.