Quality Assurance Associate II
6755 Kaiser Dr Fremont, CA 94555
Bayside Solutions is seeking a Quality Assurance Associate II 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.
Quality Assurance Associate 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:
- Responsible for executing QA operations required to assess, evaluate, and review operations against cGMPs and to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation
- Responsible for QA oversight of supplier qualification activities (review/approval of raw material and supplier qualification, management of supplier change notifications)
- Identifies, classifies and reports deviations, as appropriate and typically works on Minor, less complex deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with cross functional team members to determine root cause and potential preventative/corrective actions and ensures support for the timely closure of investigations
- Performs independent technical review and approval of documentation to support batch release (e.g. review/approval of QC testing documentation, certificate of analysis (COA), in process testing reports)
- Bachelor’ s degree, from an accredited institution, in Biology or Chemistry is preferred (or closely related degree with these core courses as the foundation) plus two (2) to four (4) years of Quality Assurance experience.
- Experience working in Quality Assurance and/or Quality Control for Pharmaceutical GMP operations
- Ability to effectively communicate both verbally and in writing to peers, superior interpersonal effectiveness and organizational skills
- Ability to work effectively on problems of diverse scope, with analysis/evaluation of data
- Attention to detail, safety, quality and customer requirements
- Ability to prioritize and make decisions in a fast paced environment
- Experience working with LIMS, SAP, Trackwise, and MS Office Applications
- Exercise independent judgment and decision making abilities
- Demonstrated knowledge of relevant regulations and
- guidances. (ie. cGMPs, SOPs, Protocols).