Specialist, Quality Assurance

About the company

CSBio is a peptide contract manufacturing organization founded in 1993. Initially focused on a complete line of automated synthesizers for manufacturing and process development, with an emphasis on cGMP production. In 1994, CSBio opened its custom peptide facility, producing high-quality compounds for research organizations and pharmaceutical companies worldwide. The company expanded its production capabilities with a peptide production facility in Menlo Park, CA, in 2004, and further enhanced its cGMP peptide production with a new state-of-the-art building in 2014. In 2017, CSBio passed an FDA inspection and was recommended for approval for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA.

Responsibilities

• Support the Quality Management System at CSBio, encompassing quality investigations including Deviations, CAPAs, and oversee Document Control, Training, and Customer Complaints.
• Provide direction, assess, and remediate current and previous validation documentation, including conducting gap assessments, risk assessments, and development of standards.
• Review and approve Out-of-Specification (OOS) results, deviations, CAPAs, SOPs, and operational documents.
• Create and provide guidance on phase-appropriate processes and systems.
• Review Risk Assessments, Process Development Reports, and Protocols.
• Provide quality support for the validation system to ensure compliance with quality and regulatory requirements in an efficient and effective manner.
• Support and approve validation-related documentation (e.g., IQ, OQ, PQ, etc.), including process, facilities, utilities, equipment, test methods, cleaning, and software validations.
• Work with Operations, Manufacturing, Quality Control, and Validation teams to maintain a validation assessment plan for all GXP assets, buildings, systems, laboratory instrumentation, and systems.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support the recall process, including initiation, customer and regulatory notification, and product withdrawal.
• Identify and manage continuous improvement projects to achieve quality and efficiency in processes.

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 Engineering, Life Sciences, Chemistry, or related field.
• 3+ years in Manufacturing or Quality Control in a pharmaceutical, medical device, or drug manufacturing company.
• 2+ years 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 90% for employee and 75% for employee's family). Dental options include Aetna Dental, Delta Dental, Guardian Dental, and MetLife Dental. Vision options include VSP and Aetna EyeMed.
• 401k: 10% 1:1 match.
• PTO policy: 10 days PTO.
• Companywide paid holidays: Week of July 4, Thanksgiving (2 days), Week of December 25.
• Life insurance: Basic life ($20,000 paid by company) and optional supplemental life insurance.
• Disability insurance: 50% standard employer-paid.
• Reimbursements: Carpool, clean air vehicle, and cell phone reimbursement.
• Employee programs: Employee rewards and recognition program, company-organized social events, and quarterly sponsored team-building activities.