Associate Manager, Quality Assurance - CSBio

CSBio is a peptide contract manufacturing 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. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

CSBio is seeking an experienced Quality Assurance Associate Manager to provide oversight in Quality Systems, API operations and validation activities including facilities, equipment, utilities, systems, process, analytical methods and cleaning validation for the Company’s GMP facility and products.

Duties include:

• Review & approve Master and Executed BPRs, OOS, deviations, CAPAs, SOPs, and operation documents.
• Authors or approves procedures, work instructions and other policy documents to strengthen CSBio Quality Systems.
• Assist in hosting and providing responses to client audits and regulatory inspections.
• Quality oversight and approval of validation related documentation (e.g., IQ, OQ, PQ, etc.). This includes process, facilities, utilities, equipment, test methods, cleaning and software validations.
• Oversee batch records and analytical data review to support lot disposition of API and raw materials,
• Lead continuous improvement projects with the objective of achieving quality and efficiency in processes, and
• Manage, develop and mentor staff.

Requirements

• Bachelor’s Degree in Chemical Engineering, Life Sciences, Chemistry or related field
• 5+ years in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company with at least 2 years of managing Validation and Quality Systems activities.
• Strong GMP knowledge and in depth understanding of ICH and FDA regulations.
• 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.

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities