Sr QA Associate
6701 Kaiser Drive Fremont, CA 94555 | Contract
Bayside Solutions is seeking a Sr. QA Associate to be part of our client’ s team in the South San Francisco. 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.
Sr. QA 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:
- Leads all paper/electronic batch record and form review that is related to manufacturing of drug substance in a multi-product facility.
- Performs duties under limited supervision and according to standard operating and manufacturing procedures.
- Contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met.
- Independently executes (paper/electronic) batch record review
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
- Responsible for executing QA operations by assessing, evaluating, and reviewing operations on the floor against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation.
- Provides guidance to Manufacturing, Engineering &Technology, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.
Summary of Qualifications:
- Requires a Bachelor’ s degree, preferably in the life science field plus a minimum of 2 years of professional experience in a GMP environment.
- In lieu of a Bachelor' s degree, will consider an Associate' s degree plus 4 years of professional experience in a GMP environment or clean room assembly environment.
- Demonstrated proficiency in MS Office programs and associated computer programs.
- Technical knowledge of manufacturing systems, methods and procedures.
- Excellent written and verbal communication skills.
- Awareness and understanding of Manufacturing processes.
- Strong independent judgment and decision making abilities.
- Strong knowledge of relevant regulatory guidance.
- Demonstrated problem-detection and problem-resolution skills.