QC Lab Leader: Regulated Quality & Compliance

Actalent

West Point (PA)

On-site

USD 90,000 - 110,000

Full time

8 days ago
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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 is seeking a Quality Control Manager to lead the QC laboratory, incoming sampling, and analytical testing across raw materials, finished products, and stability programs. You will guide a team of chemists and microbiologists, ensuring compliant, reliable results to support manufacturing and customer requirements.

You will drive continuous improvement, maintain data integrity, and uphold cGMP/cGLP standards while collaborating with cross-functional teams to meet production priorities and

Qualifications

  • Bachelor’s degree in science or related field required.
  • 5+ years of industry experience in a laboratory environment.
  • 3+ years of Quality Control management experience.
  • Experience leading a technical laboratory team in a regulated manufacturing environment.
  • Hands-on quality control/quality assurance in cGMP and cGLP settings.

Responsibilities

  • Lead and manage QC laboratory and incoming sampling activities to support operations.
  • Provide day-to-day leadership for analytical, raw material, finished product, and stability testing.
  • Coach and develop chemists and lab staff, including onboarding, training, and performance management.
  • Ensure all lab activities comply with cGMP, cGLP, safety, and regulatory requirements.
  • Maintain data integrity through robust documentation and system controls.
  • Oversee laboratory quality systems, SOP governance, deviations, CAPAs, and change controls.
  • Monitor QC performance metrics like turnaround time, first-time-right, and calibration/training compliance.
  • Partner with manufacturing and quality teams to reduce repeat issues and improve quality.
  • Develop capacity plans to support production and growth; ensure readiness for audits.

Skills

Laboratory leadership
Quality control management
HPLC
Microbiology
Analytical testing
Electronic lab systems
ERP experience
Data integrity
Regulatory compliance

Education

Bachelor’s degree in science

Tools

ERP systems
LIS / Laboratory systems

Job description

Actalent is seeking a Quality Control Manager to lead the QC laboratory, incoming sampling, and analytical testing across raw materials, finished products, and stability programs. You will guide a team of chemists and microbiologists, ensuring compliant, reliable results to support manufacturing and customer requirements.

You will drive continuous improvement, maintain data integrity, and uphold cGMP/cGLP standards while collaborating with cross-functional teams to meet production priorities and

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