GMP Documentation Specialist — Batch Records & QA

BioSpace; Irvine (CA); On-site; USD 78,000 - 88,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance, Short & Long Term DIS

Pet Insurance

Generous PTO, Sick & Holiday Time Off

401K

Job summary

Siegfried is a leading global CDMO with a long tradition in pharmaceutical manufacturing. The role centers on quality control, batch record review, and collaboration across departments to ensure compliant product release and robust investigation handling.

You will work in a team-driven environment, applying cGMPs and regulatory knowledge to maintain high safety and quality standards while contributing to continuous improvement and SOP updates.

Qualifications

• Degree in a scientific discipline with 3 to 5 years' experience in pharmaceutical manufacturing and/or testing.
• Strong problem solving and reporting writing skills.
• Proficient with GMPs, GDPs, and regulatory guidance.
• Ability to review Batch Records and ensure compliance.
• Experience with aseptic processes preferred.
• Excellent communication and teamwork skills.

Responsibilities

• Review batch records for commercial distribution and related documents.
• Coordinate production, manufacturing, and release with planning.
• Investigate deviations and customer complaints; write deviation reports.
• Monitor CAPAs and ensure effectiveness.
• Provide weekly status reports on batches and manufacturing status.
• Assist in writing and updating SOPs.

Skills

cGMP knowledge

GDP knowledge

Computer literacy

Problem solving

Teamwork

Regulatory understanding

Education

Science degree

Tools

ERP systems

Database management

Job description

Siegfried is a leading global CDMO with a long tradition in pharmaceutical manufacturing. The role centers on quality control, batch record review, and collaboration across departments to ensure compliant product release and robust investigation handling.

You will work in a team-driven environment, applying cGMPs and regulatory knowledge to maintain high safety and quality standards while contributing to continuous improvement and SOP updates.