We provide customers with technically advanced materials aimed at application performance. We focus on total solutions that consistently minimize the risk of product and process contamination. With our customer relationships we continuously focus on complete engineered clean solutions. For over 55 years, Berkshire has understood and delivered world class manufacturing, reliable supply chain, the highest standards for quality, and technically advanced products assuring mutual success each step of the way.
The Quality Control Manager is responsible for comprehensive oversight of all QC laboratory operations including receiving, in-process and finished goods testing across nonwoven, knitted, and textile materials, chemical products, and sterile/cleanroom products. Ensures compliance with ISO 9001, ISO 22716, ISO 13485, and FDA 21 CFR Part 820, including GMP, GDP, and data integrity requirements. Leads laboratory personnel, supports manufacturing and product development, and ensures testing meets all internal, customer, and regulatory specifications.
Reacts with an appropriate sense of urgency to production and customer needs.
Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering or other related disciplines.
~6+ years QC experience and 4+ years leadership experience. Experience in textiles/nonwovens/knitted, controlled cleanroom and sterile manufacturing environments, and/or regulated industries (including medical device and/or cosmetic GMP-regulated environments) preferred.
~ Proficiency in Microsoft Office, ERP, and LIMS systems.
~Ability to use judgement in the analysis of facts and circumstances surrounding individual problems and transactions and in the determination of action to be taken within the limits of standard or accepted practice.
~ Ability to apply complex instructions that include conditionals to situations described in materials.
~ Ability to use precision measuring instruments including equipment and personal computers to input data involving advanced skills knowledge.
maintain staffing coverage aligned with production and QC needs.
~ Conduct performance evaluations on direct reports and works to develop employees’ knowledge, skills and abilities.
~ Ensure laboratory compliance with ISO 9001, ISO 22716, ISO 13485, and 21 CFR Part 820 regulations (including equipment calibration and process controls).
~ Maintain lab records, ensure data integrity (ALCOA+), and manage migration to LIMS/QMS systems.
~ Support CAPA, change control, nonconforming materials management, and root cause investigations.
~ Complete projects by assisting project teams, attending and participating in group and project meetings.
~Ensure the lab performs routine quality assurance/quality control testing and inspection of manufactured products to verify conformance to specifications.
~ Oversee test results and the analysis on Product Development samples and samples submitted by overseas affiliates.
~ Manage the maintenance of all lab-related paperwork and records; audit laboratory data; Use statistical techniques to identify adverse trends in data and data “outliers” established in partnership with the Quality Manager.
~ Ensure laboratory equipment is calibrated according to standards for proper manufacturing monitoring and measuring; perform routine maintenance on lab equipment.
~ Develop, review, validate, and approve test methods, SOPs, and data sheets to ensure compliance with ISO and FDA requirements.
~ Ensure that each person has sufficient information, resources, and materials to do their job safely and safety protocol is being followed.
~ Establish and maintain proper levels for lab supplies by inventorying stock, placing orders, and verifying receipt.
~Ensures team adheres to internal standards, policies, and procedures.
~ Partners with the Quality Assurance Department (Certificates, Photos, Environmental Monitoring, etc) to ensure compliance, when applicable.
~ Partner with 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, sampling, etc.
~ Assist in troubleshooting production problems and process/product improvement and development.
~ Provide tours and overview of the QC Laboratory process to customers and additional visitors.
~ Oversee all testing performed in the lab and the preparation of chemical solutions according to standard formulae.
~ Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
~ Performs other duties as assigned by Quality Director.
Seek exposure to outside training opportunities and membership in at least one professional organization.
~Hands to finger, feel, and handle testing equipment and product; operate computer.
Occasional work near moving mechanical parts.
Exposure to fumes or airborne particles and toxic or caustic chemicals.
Medical Insurance.
~ Dental Insurance.
~ Life and Voluntary Life Insurance.
~ Short- and Long-Term Disability.
~ Flexible Spending with Company Match.
~401(k) Retirement Savings Plan with Company Match.
~ Paid Holidays.
~ Personal/Sick.
~ EAP Program.
~ Tuition Reimbursement.
