90 Digital Drive Novato, CA 94949
Bayside Solutions is seeking a QA Associate 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.
- 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:
- Conduct laboratory, environmental monitoring (alert, action) and deviation investigations in the QC and QA Operations areas.
- Facilitate investigation related meetings, including root cause analysis.
- Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented. These reports may be related to manufacturing, facilities, QA or QC related events.
- Monitor trackwise record workflows and report metrics to area manager.
Summary of Qualifications:
- Minimum 3 years’ relevant experience in a cGMP regulated QC laboratory, with exhibited knowledge and proficiency in investigations (investigator and QA approver roles).
- Experience and ability to work cross functionally as needed.
- Experience in supporting Quality Operations is highly desirable.
- Strong ability to facilitate investigational meetings autonomously.
- Ability to track work and present metrics to management as needed.
- Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.