Quality Control Lab Manager – cGMP & Compliance Lead

Actalent; West Point (PA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical care

Dental Care

Vision

Pet Insurance

401K with match

Wellness program

9 paid holidays

2 weeks vacation

Job summary

Actalent seeks a Quality Control Manager to lead the QC laboratory, incoming sampling, and stability testing in our West Point, PA facility. You will direct chemists, microbiologists, analysts, and staff while ensuring safe, compliant analytical support for operations and customers.

The role emphasizes cGMP/cGLP compliance, data integrity, and continuous improvement, with collaboration across manufacturing, quality, and regulatory teams to meet evolving expectations.

Qualifications

• Bachelor's degree in science discipline required.
• Minimum 5 years of industry lab experience.
• Minimum 3 years in Quality Control management.
• Demonstrated leadership of a technical laboratory team in regulated manufacturing.
• Hands-on QC/QA in cGMP/cGLP environments.
• Strong knowledge of laboratory quality systems (change control).
• Experience with analytical testing operations and stability programs.
• Proficiency with electronic laboratory systems and ERP.
• Technical expertise in HPLC, microbiology, raw material and finished product testing.
• Proven ability to lead people and manage performance.

Responsibilities

• Lead QC lab and incoming sampling for manufacturing operations.
• Provide day-to-day leadership for analytical testing and stability programs.
• Coach and develop chemists, microbiologists, analysts, and lab staff.
• Ensure compliance with cGMP, cGLP, safety, and regulatory requirements.
• Maintain data integrity and robust documentation practices.
• Oversee QC quality systems and CAPAs, deviations, and change controls.
• Monitor metrics like turnaround time, first-time-right, calibration, and deviations.
• Collaborate with manufacturing and quality teams to fix root causes.
• Develop capacity plans to meet production and new business needs.
• Prepare for audits and ensure readiness for internal and external inspections.

Skills

Bachelor level degree

5+ years lab experience

3+ years QC management

Regulated manufacturing

cGMP/cGLP knowledge

Laboratory leadership

Analytical testing knowledge

Electronic lab systems

ERP experience

HPLC expertise

Education

Bachelors in science

Tools

HPLC

Laboratory instruments

Electronic Lab Systems

ERP systems

Job description

Actalent seeks a Quality Control Manager to lead the QC laboratory, incoming sampling, and stability testing in our West Point, PA facility. You will direct chemists, microbiologists, analysts, and staff while ensuring safe, compliant analytical support for operations and customers.

The role emphasizes cGMP/cGLP compliance, data integrity, and continuous improvement, with collaboration across manufacturing, quality, and regulatory teams to meet evolving expectations.