Quality Control Manager — GMP Analytics Lead

Bachem Americas, Inc.; Vista (CA); On-site; USD 109,000 - 183,000; Full time

Job summary

Bachem Americas, Inc. is seeking a Manager/Sr. Manager of Quality Control to lead analytical testing operations for API, raw materials and final products.

You will coordinate internal and external lab activities, review data, and drive method development and GMP compliance. The role requires strong supervisory skills, SOP writing, and effective communication to ensure timely release and continuous improvement of QC processes.

Qualifications

• Bachelor's degree in a relevant scientific field and 8+ years in the industry.
• Master's degree in a relevant field with 5+ years in the industry (preferred).
• PhD in a relevant field with 2+ years in the industry (preferred).
• Management experience and project management experience preferred.
• GMP laboratory testing experience and analytical chemistry knowledge.

Responsibilities

• Oversee QC testing including IPC, API, raw materials, validation and release.
• Supervise QC scientists; provide training, scheduling, mentoring and coaching.
• Establish specifications and sampling plans for IPC and materials.
• Develop and optimize analytical methods for qualification and release testing.
• Coordinate stability programs and ensure endpoints are met.
• Manage release activities to meet manufacturing deadlines.
• Author and review QC SOPs and test methods.
• Evaluate new analytical technologies and instrumentation.
• Investigate OOS results and implement CAPA actions.
• Manage external labs for contract testing and data reviews.

Skills

Excellent written and oral comms

Attention to detail

Project management

Team leadership

Problem solving

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field (preferred)

PhD in a relevant field (preferred)

1-3 years management experience (preferred)

Tools

HPLC

GC

TLC

UV-VIS Spectrophotometer

Karl Fisher Titrator

FTIR

MS

LAL

bioburden testing

Job description

Bachem Americas, Inc. is seeking a Manager/Sr. Manager of Quality Control to lead analytical testing operations for API, raw materials and final products.

You will coordinate internal and external lab activities, review data, and drive method development and GMP compliance. The role requires strong supervisory skills, SOP writing, and effective communication to ensure timely release and continuous improvement of QC processes.