Senior QC Lab Manager — Cleanroom Materials & Compliance

RXinsider LTD.; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life and Voluntary Life Insurance

Short- and Long-Term Disability

401(k) Retirement Savings Plan with 회사

Paid Holidays

Paid Vacation

Personal/Sick

EAP Program

Tuition Reimbursement

Job summary

Berkshire Corporation is seeking a proactive Quality Control Manager to oversee QC laboratory operations across nonwoven, knitted, and textile materials, chemical products, and sterile/cleanroom products.

The role requires leadership, integrity, and a detailed, solution‑driven mindset to ensure compliance with ISO 9001, ISO 22716, ISO 13485, and FDA 21 CFR Part 820. Expect collaboration with manufacturing and product development teams.

Qualifications

• Bachelor's degree in a related science/engineering discipline.
• 6+ years QC experience and 4+ years leadership experience preferred.
• Experience in textiles/nonwovens/knitted, controlled cleanroom and sterile manufacturing environments.
• Proficiency with ERP, LIMS, and MS Office; data integrity focus.

Responsibilities

• Supervise, lead, and train laboratory personnel; ensure staffing aligns with production and QC needs.
• Conduct performance evaluations and develop team knowledge and skills.
• Maintain ISO 9001, ISO 22716, ISO 13485, and 21 CFR Part 820 compliance incl. calibrations.
• Maintain lab records, data integrity, and migration to LIMS/QMS systems.
• Support audits (internal, external, FDA) and CAPA processes.
• Oversee testing, data analysis, and reporting for product development and overseas samples.

Skills

Leadership

Attention to detail

Communication skills

Analytical skills

Multitasking

Education

Bachelor's degree in Chemistry/ Biology/ Microbiology/ Engineering

Tools

ERP

LIMS

Microsoft Office

Job description

Berkshire Corporation is seeking a proactive Quality Control Manager to oversee QC laboratory operations across nonwoven, knitted, and textile materials, chemical products, and sterile/cleanroom products.

The role requires leadership, integrity, and a detailed, solution‑driven mindset to ensure compliance with ISO 9001, ISO 22716, ISO 13485, and FDA 21 CFR Part 820. Expect collaboration with manufacturing and product development teams.