Senior Quality Control Leader: GMP Analytics & Release

Bachem; Vista (CA); On-site; USD 133,000 - 183,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem, a leading API manufacturer, seeks a Sr. Manager to lead Quality Control activities in Vista, CA. You will oversee QC testing, regulatory compliance, and a team of QC scientists, while coordinating internal and external labs to ensure strict release criteria are met.

You will drive method development, stability programs, CAPA execution, and SOP creation, contributing to overall QC capabilities and performance within a fast-paced, GMP environment.

Qualifications

• Bachelor's degree in a scientific field with 12+ years of experience.
• Master's degree with 9+ years of experience (preferred).
• PhD with 6+ years of experience (preferred).
• 4+ years management experience.
• 1-3 years project management experience (preferred).
• Extensive GMP lab testing experience (IPC, HPLC, GC, TLC, UV-VIS, FTIR, MS, LAL).
• Strong analytical chemistry knowledge including USP testing.
• Excellent communication and problem-solving skills.

Responsibilities

• Oversee QC testing including IPC, API, raw materials, validation and release.
• Supervise QC scientists with training, scheduling, mentoring and coaching.
• Set specifications and sampling plans for IPC, materials and final product.
• Develop and optimize analytical methods for qualification and release testing.
• Coordinate stability program and testing to meet endpoints.
• Manage release activities to align with manufacturing schedules.
• Write, review and approve QC SOPs as needed.
• Evaluate new analytical technologies and instrumentation for testing.
• Investigate OOS results, write reports and implement CAPAs.
• Manage external contract labs for testing and data review.
• Provide timely responses to inquiries and stay updated on innovations.
• Contribute to GMP improvements and laboratory efficiency.

Skills

Communication skills

Project management

Analytical thinking

Team leadership

Education

Bachelor's degree in a scientific field

Master's degree in a scientific field

PhD in a scientific field

Tools

Microsoft Word

Excel

PowerPoint

Access

Job description

Bachem, a leading API manufacturer, seeks a Sr. Manager to lead Quality Control activities in Vista, CA. You will oversee QC testing, regulatory compliance, and a team of QC scientists, while coordinating internal and external labs to ensure strict release criteria are met.

You will drive method development, stability programs, CAPA execution, and SOP creation, contributing to overall QC capabilities and performance within a fast-paced, GMP environment.