Quality Operations Specialist - GMP & Data Integrity

20BLOC; Thousand Oaks (CA); On-site; USD 82,000 - 109,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Job summary

A biopharmaceutical company in Thousand Oaks, California is seeking a Quality Operations Specialist. The role encompasses ensuring GMP compliance, supporting batch documentation review, and collaborating with cross-functional teams. Ideal candidates will have a Bachelor's degree in Life Sciences and 4+ years of experience in Quality Assurance. Competitive compensation and benefits are offered along with a full-time, on-site work environment.

Qualifications

• 4+ years of experience in Quality Assurance within a GMP-regulated environment.
• Hands-on experience with batch record review and analytical data review.
• Experience managing deviations, change control, and SOPs.
• Familiarity with regulatory requirements (e.g., FDA, EMA).

Responsibilities

• Review and approve manufacturing batch records and analytical data.
• Initiate and document deviations, including CAPA development.
• Support internal audits and regulatory inspections.
• Collaborate with cross-functional teams to resolve quality issues.

Skills

Quality Assurance

GMP compliance

Root cause analysis

Documentation skills

Analytical data review

Organizational skills

Collaboration

Effective communication

Education

Bachelor’s degree in Life Sciences or a related field

Tools

Electronic QMS systems

Job description

A biopharmaceutical company in Thousand Oaks, California is seeking a Quality Operations Specialist. The role encompasses ensuring GMP compliance, supporting batch documentation review, and collaborating with cross-functional teams. Ideal candidates will have a Bachelor's degree in Life Sciences and 4+ years of experience in Quality Assurance. Competitive compensation and benefits are offered along with a full-time, on-site work environment.