Production and Quality Associate
1541 Industrial Rd San Carlos, CA 94070
Bayside Solutions is seeking a Quality and Production Associate to be part of our Client’ s team in the Peninsula. This is an opportunity to work with a molecular diagnostics company that engages in the detection and monitoring of life threatening viral diseases in the areas of cervical cancer, HIV/AIDS, hepatitis, breast and ovarian cancer, and organ transplant rejection.
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 and Production Associate
- An opportunity to join a company focused on the development and delivery of novel, targeted drugs for treating a variety of therapeutic areas.
- Work for a company that is local to the bay area.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Receive and inspect production materials, perform functional testing, and document conformance to specifications
- Perform hands-on cell-based molecular laboratory testing for quality control of product and materials
- Perform a range of internal manufacturing procedures, including cell line expansion and isolation, filling, product labeling, packaging and assembly
- Ensure proper receiving, labeling and location of materials according to company SOPs; assist in offsite storage facility management
- Perform monthly inventory of products for accounting
- Order and maintain QC reagents and supplies for internal testing
- Maintain manufacturing and QC equipment as necessary
- Write, revise and review Quality Control and Manufacturing documents
- Investigate and document Non Conformance Reports and Corrective and Preventive Actions reports as needed
- Trend quality control and product performance results
- Assist with Design Transfer documentation for the Design History File of new products
- Act as a back-up for shipping related activities
- Be periodically on-call outside of business hours to ensure 24/7 temperature monitoring for products.
- Conduct technical studies to support Quality Control, Manufacturing and Product Development; write technical protocols and reports
- Design and perform stability studies to verify product shelf life; write study reports to summarize results
- Work cross functionally as needed to support all company and department objectives.
- BS in Biochemistry, Molecular Cell Biology or related field
- Minimum of 2 years of Quality Control experience with molecular or cell-based assays
- Minimum 1 year of mammalian cell culture experience
- Experience working in a GMP environment; good understanding of FDA Quality System Regulation and/or ISO 13485
- Highly detail-oriented and organized, yet flexible
- Proficient in using basic lab equipment (micro-pipettors, microcentrifuge, cell analyzer)
- Effective computer skills, especially proficient in Excel and Word
- Excellent written and verbal communication skills; the employee must be able to read, write, and communicate fluently in English
- Comfortable in a quick-paced environment, able to shift priorities when needed. Ability to multitask
- Excellent interpersonal and organizational skills
- Effective problem solving, troubleshooting and analytical skills
- Flow cytometry experience is a plus