Specialist, 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.

Job Duties:

• Review/approve Master and Executed BPRs, OOS, deviations, CAPAs, SOPs, analytical test methods, and other 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, raw material release, and product shipping and labeling.
• Lead continuous improvement projects with the objective of achieving quality and efficiency in processes.
• Conduct qualification activities on suppliers, contact labs and service providers

Competencies:

• To perform the job successfully, an individual should demonstrate the following competencies:
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.

• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed.

• Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values.

• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence.

• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Requirements

• Bachelor’s Degree in Life Sciences, Chemistry, or related field
• 5+ years experience in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company
• 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