Quality Control Associate I
1000 New Horizons Way, VAC10 Vacaville, CA 95688
Bayside Solutions is seeking a Quality Control Associate I to be part of our client’ s team in Vacaville. 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.
QC Associate I
- 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 a broad variety of basic and moderately complex tests with documentation according to GMP
- Review data and assess against established acceptance criteria
- Perform technical review of peer-generated data
- Evaluate data to identify trends and/or establish limits
- Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
- Identify and troubleshoot technical problems
- Identify gaps in systems and procedures
- Receive and provide training
- Participate in assay transfer and assay validation
- Perform equipment qualification / maintenance
- Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures
- Support the maintenance and compliance of operational areas
- Assure and apply GMP throughout operations
- Coordinate with customers to support multi-site operational activities
- Support internal and external audits and regulatory inspections
- Works to meet schedules, timelines, deadlines
- Participate in and/or lead group and project teamwork; project and process improvements
- Write protocols and reports under limited supervision
- Meets scheduled performance of 95% on time
- Perform other duties as requested by managers to support Quality activities
Summary of Qualifications:
- B.S. /B.A. degree and 2 years’ experience or Master’ s Degree plus 1 year experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
- Strong verbal and written communication skills, ability to organize and present information both formally and informally.
- Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
- Routinely exercises sound judgment, reasoning and problem solving.
- Capable of working under moderate supervision and determining own short-term priorities.
- Physical requirements - Prolonged periods of standing at lab bench top. Frequent lifting (up to 10
- lbs), bending, reaching, twisting. Use of step ladders and push carts required.
- Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
- Pass visual screening, as required