Senior QA Specialist - GMP & Document Control

Bachem; Vista (CA); On-site; USD 87,000 - 120,000; Full time

Benefits offered by this job

Total rewards package

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem Americas in Vista, CA is seeking a Quality Assurance Specialist III with emphasis on Document Control. You will contribute to GMP system improvements, review technical documents, and provide QA guidance and data analysis. This role may assist the QA Manager as a deputy when needed.

You will lead real-time batch record reviews, support audits, and help train other departments to strengthen quality culture across sites. Strong communication and GMP experience are essential.

Qualifications

• BSc in organic chemistry or related field required.
• MS in organic chemistry preferred.
• 5+ years GMP manufacturing experience or 7+ years with an Associate degree.
• 4-6 years QA and GMP document control experience.
• Experience in ISO7/ISO8 environments and real-time batch review.
• Auditing experience with regulators is preferred.
• Excellent written and oral communication skills.

Responsibilities

• Perform duties of QA Specialist I/II in addition to listed tasks.
• Support real-time batch record review and electronic batch release decisions.
• Suggest GMP improvements and LEAN GMP initiatives.
• Review and approve GMP docs: BPRs, validation protocols, data, reports.
• Analyze and trend data to extract key information.
• Collaborate across functions/sites to close quality records and changes.
• Propose new policies to improve processes and products.
• Lead GMP system problem resolutions and provide guidance.
• Contribute to quality culture through guidance and training.
• Conduct internal GMP audits and support customer/authority audits.
• Draft and revise SOPs and production/quality system docs.

Skills

Excellent communication

Detail oriented

Time management

Team collaboration

Proactive problem solving

Independent work

Education

Bachelor's in organic chemistry or related field

Master's in organic chemistry or related field

Associate's in science with 7+ years GMP exp

Certified Quality Process Analyst (ASQ)

CQE certification desired

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Bachem Americas in Vista, CA is seeking a Quality Assurance Specialist III with emphasis on Document Control. You will contribute to GMP system improvements, review technical documents, and provide QA guidance and data analysis. This role may assist the QA Manager as a deputy when needed.

You will lead real-time batch record reviews, support audits, and help train other departments to strengthen quality culture across sites. Strong communication and GMP experience are essential.