Specialist, QA Lot Release
Novato, CA | Contract
Bayside Solutions is seeking a Specialist, QA Lot Release to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.
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. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.
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 atwww.baysidesolutions.com.
Specialist, QA Lot Release
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
- Inspection, Review and Disposition of raw material lot files per company’ s SOPs
- Enter raw material lot disposition in LIMS and other databases, as applicable
- Maintain electronic status control for cGMP raw materials
- Understand the Materials Management and QC raw materials procedures to ensure raw material lot files are compliant with these systems.
- Provide QA verification of transfer of FBDS from Manufacturing to Quarantine storage
- Perform QA approval of OWK pre-weight kits
- Perform QA inspection of primary packaging components
- Provide QA support to other QA raw materials activities: company reserve sample program, in-house label production, control of rejected materials, and in-process materials returned from contract sites.
- Bachelor of Science degree in Biology, Biochemistry, Chemistry or related field
- 0-4 year’ s previous experience in a GMP environment.
- Attention to detail, organized, ability to work independently with minimal supervision.
- Primary job function is documentation review, both paper and computer documents.
- Familiarity with Microsoft Office PC, experience with LIMS or other similar databases a plus.