Specialist, Quality Assurance

CSBio - Menlo Park, CA2.0

30+ days ago
CSBio is a fast-paced growing peptide CMO founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing.

We are seeking a qualified individual to join us as a Quality Assurance Specialist at our Menlo Park facility. Job responsibilities include the following:

Conduct Batch Product Record (BPR) review, QC release test and stability test records review, and lot disposition for GMP products
Review lot disposition for materials
Review and approve stability reports
Initial, review, and approve other documents such as SOPs and study protocols
Release equipment and room for GMP use
Support Document Control activities and other Quality Assurance functions as needed
Review and approve Validation related documentation including process, facilities, utilities, equipment, test methods, cleaning, and software validation
Acquire and analyze data to facilitate process, method, and improvements
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Master’s Degree in Pharmaceutical Manufacturing or related field
2+ years experience in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company
Thorough understanding of problem-solving and quality improvement tools and techniques
Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment

Competitive pay commensurate with experience
Medical, dental, and vision insurance
Basic life and supplemental life insurance
401k with matching up to 5%
Flexible PTO policy
Carpool, clean air vehicle, and cell phone reimbursement
Free shuttle program (trans-bay)
Employee rewards and recognition program
Free access to fitness center
Social events and catered lunch on Sat/Sun