QC Manager

About Berkshire Berkshire is the global contamination control leader for cleanroom and controlled environment consumable products. We provide customers with technically advanced materials that improve application performance and consistently minimize the risk of product and process contamination. With over 55 years of experience, we maintain world‑class manufacturing, a reliable supply chain, the highest standards for quality, and technically advanced products to ensure mutual success at every step. Job Overview The Quality Control Manager oversees all QC laboratory operations, including receiving, in‑process, and finished goods testing across nonwoven, knitted, textile, chemical, and sterile/cleanroom materials. The role ensures compliance with ISO 9001, ISO 22716, ISO 13485, FDA 21 CFR Part 820, and related GMP, GDP, and data‑integrity requirements. The manager leads laboratory personnel, supports manufacturing and product development, and guarantees that testing meets internal, customer, and regulatory specifications. Responsibilities Supervise, lead, and train laboratory personnel; maintain staffing coverage aligned with production and QC needs. Conduct performance evaluations on direct reports and develop employees’ knowledge, skills, and abilities. Ensure laboratory compliance with ISO 9001, ISO 22716, ISO 13485, and 21 CFR Part 820, including equipment calibration and process controls. Maintain lab records, ensure data integrity (ALCOA+), and manage migration to LIMS/QMS systems. Support internal, external, and FDA audits and maintain audit readiness. Support CAPA, change control, nonconforming material management, and root‑cause investigations. Assist project teams, attend meetings, and participate in group projects. Perform routine QA/QC testing and inspection of manufactured products to verify conformance to specifications. Oversee test results and analysis on product development samples and samples submitted by overseas affiliates. Manage maintenance of all lab‑related paperwork and records; audit laboratory data; prepare reports, graphs, and charts as required. Use statistical techniques to identify adverse trends in data and data outliers in partnership with the Quality Manager. Ensure laboratory equipment is calibrated according to standards and perform routine maintenance on lab equipment. Determine priority status of all samples in each day’s lab batch and expedite processing to meet client requirements. Develop, review, validate, and approve test methods, SOPs, and data sheets to ensure compliance with ISO and FDA requirements. Ensure each technician has undergone orientation and possesses sufficient knowledge for safety while working. Ensure that all personnel have necessary information, resources, and materials to perform their job safely and that safety protocols are followed. Establish and maintain proper levels of lab supplies by inventorying stock, placing orders, and verifying receipt. Ensure adherence to internal standards, policies, and procedures. Partner with the Quality Assurance Department (Certificates, Photos, Environmental Monitoring, etc.) to ensure compliance. Collaborate with the Chemical Hygiene Officer to manage chemicals used and stored in the lab and ensure proper disposal. Assist with the non‑conforming material process, including reporting and sampling. Contribute to troubleshooting production problems and process or product improvement and development. Provide tours and overviews of the QC laboratory process to customers and visitors. Oversee all testing performed in the lab and the preparation of chemical solutions according to standard formulae. Perform other duties as assigned by the Quality Director. Qualifications Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or related discipline. 6+ years QC experience and 4+ years leadership experience in textiles/nonwovens/knitted, controlled cleanroom and sterile manufacturing, or regulated industries (medical device and/or cosmetic GMP environments) preferred. Proficiency in Microsoft Office, ERP, and LIMS systems. Strong attention to detail and commitment to compliance. Ability to independently make decisions and lead a department of lab technicians. Proficient multitasking and excellent organizational skills. Excellent interpersonal and leadership skills to develop and mentor department staff. Competent use of advanced mathematics, specifications, charts, tables, and handbook formulas for presentations. Ability to solve complex, multi‑step logic and calculation problems. Judgment in analyzing facts and circumstances and determining appropriate action within accepted practice. Ability to interpret written, oral, diagrammatic, or schedule instructions. Ability to apply complex conditional instructions to situations. Ability to apply technical terms and jargon and relate them to stated situations. Proficiency in using precision measuring instruments, equipment, and personal computers to input advanced data. Job Expectations Dedicate required time to accomplish job responsibilities. Continuously build knowledge and skills and share expertise with others. Seek external training opportunities and membership in at least one professional organization. Adhere to Berkshire’s Code of Conduct and Professional Ethics Standards. Physical Requirements Frequent standing, sitting, reaching with hands and arms. Occasional lifting and moving of up to 25 lbs. Occasional work near moving mechanical parts. Occasional walking, climbing, balancing, stooping, crouching, crawling, and smelling. Close, peripheral, and depth perception vision. Quiet work environment. Exposure to fumes, airborne particles, and toxic or caustic chemicals. Ability to gown per ISO Class 4 and 6 environments (smock, latex gloves, bonnet, mask). Benefits Medical Insurance Dental Insurance Vision Insurance Life and Voluntary Life Insurance Short‑Term and Long‑Term Disability Flexible Spending with Company Match 401(k) Retirement Savings Plan with Company Match Paid Holidays Paid Vacation Personal/Sick Leave EAP Program Tuition Reimbursement These statements are intended to describe the general nature and level of work being performed by employees assigned to this job. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this job. #J-18808-Ljbffr