GMP QC Scientist - Analytical & Release Testing

Bachem Holding AG; Vista (CA); On-site; USD 62,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Medical/Dental/Vision

401(k) plan

Job summary

Bachem Americas in Vista, CA, seeks a Quality Control Scientist to perform daily QC operations, test raw materials and final product, and ensure GMP compliance. You will write and revise control documents, review data, and support calibration and validation of analytical methods.

The role requires strong attention to detail, teamwork, and flexibility to meet production needs. Responsibilities include executing tests (HPLC/UPLC, GC, UV, Mass Spec), maintaining equipment, and contributing to the

Qualifications

• Bachelor’s degree in chemistry or related field required.
• Master’s degree in chemistry or related field preferred.
• Minimum of 3 years' experience in GMP pharma/biotech facility.
• Experience with Equipment Maintenance Programs.
• Experience with analytical techniques/instruments including GC, HPLC/UPLC, and UV-Spectrophotometer.
• Excellent written and oral communication skills.
• Proficient computer skills (Word, Excel, PowerPoint).
• Ability to multitask and work in a fast-paced, deadline-driven environment.
• Strong proactive communication and issue-resolution mindset.
• Detail-oriented with troubleshooting skills.
• Ability to work independently and as part of a team.
• Ability to review CoA and create specifications/documents.
• Strong organization to support controlled document workflows.
• Flexibility with working hours, occasional nights/weekends.

Responsibilities

• Maintain and perform daily QC operations in coordination with QC Director/Supervisor; test raw materials and peptides.
• Write and revise control documents such as specifications, SOPs, and STMs.
• Verify QC equipment for GMP compliance in coordination with QC Director/Supervisor.
• Implement and maintain GMP procedures and proper documentation.
• Test, review, and release raw materials used in manufacturing for GMP compliance.
• Test and release final product peptide and in-process samples.
• Maintain cGMP quality through training, documentation and procedures.
• Write/revise specifications and GMP documentation; ensure accuracy.
• Perform QC analyses (HPLC, UPLC, GC, UV, Mass Spec, etc.) and validate methods.
• Control raw materials through receiving, quarantine, testing, and QC release.
• Investigate deviations or out-of-spec results per supervisor directions.
• Execute validations to support QC analytical methods and other validations.
• Follow safety guidelines in handling toxic chemicals and large volumes.

Skills

GMP experience

Documentation skills

Communication skills

Multitasking

Teamwork

Education

Bachelor’s degree in chemistry or related field

Master’s degree in chemistry or related field (preferred)

Tools

GC

HPLC/UPLC

UV-Spectrophotometer

Job description

Bachem Americas in Vista, CA, seeks a Quality Control Scientist to perform daily QC operations, test raw materials and final product, and ensure GMP compliance. You will write and revise control documents, review data, and support calibration and validation of analytical methods.

The role requires strong attention to detail, teamwork, and flexibility to meet production needs. Responsibilities include executing tests (HPLC/UPLC, GC, UV, Mass Spec), maintaining equipment, and contributing to the