QC Analyst II
300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a Quality Control Analyst II to be part of our client’ s team in Novato. 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.
Quality Control Analyst II:
- 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:
- Perform laboratory testing of client drug products and API’ s
- Analyze and review quality control release and stability testing data of client’ s pharmaceutical products at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs)
- Support the preparation of phase-appropriate stability protocols and stability reports for API and drug product in accordance with regulatory requirements and as needed to support clinical trials and regulatory submissions
- Support investigations conducted at CMO/CTL and review and approve out-of-specification (OOS), out-of-trend (OOT) and out-of-expectation (OOE) testing results, deviations.
- Support the transfer of analytical methods to CTL’ s for gene therapy products. These methods may include HPLC, ELISA, and other methods, such as cell-based potency methods.
- Support continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
- Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data.
Summary of Qualifications:
- BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 - 2 years professional experience).
- MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 years professional experience).
- Relevant experience in a Quality Control function at an Analyst or technician level is highly preferred.
- Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is preferred.
- Basic understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP is required as applied to biologics is preferred.
- Demonstrated experience with passaging cells and cell-based methods is highly preferred. Experience with PCR and molecular biology methodologies is preferred.
- Ability to effectively prioritize and deliver on tight timelines in a fast-paced environment.
- Excellent written and verbal communication skills is required.
- Experience in analytical data systems is preferred.
- Accuracy and attention to detail is required.
- Excellent cross-functional team participation skills.
- Basic problem-solving abilities.
- Ability to be flexible with changing work needs
- Interacts with other functional leaders, project management and QC/AD team personnel
- Interacts with Contract Testing Laboratories, Contract Manufacturing Organizations, consultants and external partners