GMP Quality Assurance Specialist - Validation & Compliance

CSBio; United States; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Healthcare insurance

401k plan

Paid time off

Paid holidays

Life insurance

Disability insurance

Carpool reimbursement

Employee recognition program

Team building activities

Job summary

CSBio is a peptide contract manufacturing company seeking a Quality Assurance professional to support the Quality Management System and validation activities across GMP operations at our Menlo Park/Milpitas facilities.

You will review OOS, deviations, CAPAs, SOPs and operation documents, provide guidance on phase-appropriate processes, and collaborate with Operations, Manufacturing, Quality Control and Validation to sustain compliant, efficient production.

Qualifications

• Bachelor’s degree in a relevant 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 in a cross-functional team within a fast-paced environment.

Responsibilities

• Support Quality Management System at CSBio encompassing quality investigations including Deviations, CAPAs, and oversee Document Control, Training and Customer Complaints.
• Provide direction, assess and remediate validation documentation, including gap assessments, risk assessments, and development of standards.
• Review/approve OOS, deviations, CAPAs, SOPs, and operation documents.
• Create and provide guidance on phase-appropriate processes and systems.
• Review Risk Assessments, Process Development Reports, and Protocols.
• Quality support of the validation system to ensure compliance.
• Quality support and approval of validation related documentation (IQ, OQ, PQ, etc.).
• Work with Operations, Manufacturing, Quality Control, and Validation to maintain a validation assessment plan for all GXP assets, buildings, systems.

Skills

Problem solving

Teamwork

Organizational skills

Adaptability

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering, Life Sciences, Chemistry, or related field

Tools

GxP compliance tools

Job description

CSBio is a peptide contract manufacturing company seeking a Quality Assurance professional to support the Quality Management System and validation activities across GMP operations at our Menlo Park/Milpitas facilities.

You will review OOS, deviations, CAPAs, SOPs and operation documents, provide guidance on phase-appropriate processes, and collaborate with Operations, Manufacturing, Quality Control and Validation to sustain compliant, efficient production.