GMP Quality Control Lead & Lab Analytics

Polysciences, Inc.; Warrington Township (Bucks County); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical Plans

Dental Plans

401(k) with company match

Paid Time Off

Paid Holidays

Life Insurance

Disability Insurance

Flexible Spending Accounts

Job summary

Polysciences, Inc. is seeking a seasoned Quality Control Lead to oversee QC activities across analytical testing for manufacturing and product release. You will mentor analysts, manage testing schedules, and ensure data integrity and compliance with ISO 13485 and FDA GMP standards.

The role emphasizes leadership, process improvement, and cross-functional collaboration with production, planning, and procurement to maintain quality and drive efficiency in a fast-paced lab environment.

Qualifications

• Bachelor’s Degree in Chemistry or related science field required.
• Six Sigma or related certification required.
• At least five (5) years of experience in ISO 13485 or FDA GMP environment.
• Proven leadership abilities and experience coaching teams.
• Experience with GMP documentation and data integrity.

Responsibilities

• Provide leadership and mentoring to QC team.
• Coordinate testing schedules for raw materials, in-process, intermediates, and finished goods.
• Maintain 5S and a safe, organized QC environment.
• Lead investigations of OOS and deviations with timely reporting.
• Review and approve QC procedures and test methods.
• Collaborate with production, planning, and procurement to ensure timely analysis.
• Drive continuous improvement initiatives (Six Sigma, Lean, TQM).
• Oversee laboratory equipment maintenance and data integrity.

Skills

Leadership

Six Sigma

Quality control

Coaching

Education

Bachelor’s Degree in Chemistry

Tools

GC-MS

GC-FID

LC-DAD

LC-MS

NMR

TGA

DSC

Job description

Polysciences, Inc. is seeking a seasoned Quality Control Lead to oversee QC activities across analytical testing for manufacturing and product release. You will mentor analysts, manage testing schedules, and ensure data integrity and compliance with ISO 13485 and FDA GMP standards.

The role emphasizes leadership, process improvement, and cross-functional collaboration with production, planning, and procurement to maintain quality and drive efficiency in a fast-paced lab environment.