Quality Control Manager

Quality Control Manager

Berkshire is the global contamination control leader for cleanroom and controlled environment consumable products. 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.

Berkshire Corporation is looking for a proactive, detail-oriented strategist who balances independent initiative with a collaborative spirit. The ideal candidate is a professional of high integrity who tackles complex problems with a positive, solution-focused mindset.

Description of Candidate

• Demonstrate integrity and professionalism.
• Demonstrate a positive attitude in the face of challenges.
• Maintain a professional demeanor with both internally and externally with vendors and suppliers.
• Maintain a high attention to detail to ensure compliance to standards.
• Ability to work individually as well as positively and proactively in a team.
• Reacts with an appropriate sense of urgency to production and customer needs.
• Ability to read and comprehend written instructions.

Qualifications of Candidate

• 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
• Attention to detail and commitment to compliance
• Be able to independently make decisions and lead a department of Lab Technicians.
• Proficiently and knowledgeably multitask and have excellent organizational skills.
• Possess excellent interpersonal and leadership skills to develop and mentor/coach department staff.
• Competently use advanced mathematics together with the use of specifications, charts, tables, and handbook formulas for presentations.
• Ability to solve problems which require several steps of logic and calculation.
• 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 interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to apply complex instructions that include conditionals to situations described in materials.
• Ability to apply technical terms and jargon and relate them to stated situations.
• Ability to use precision measuring instruments including equipment and personal computers to input data involving advanced skills knowledge

Job Description

• Supervise, lead, and train laboratory personnel; 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 audits (internal, external, FDA) and ensure audit readiness at all times.
• 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; prepare reports, graphs, and charts as required.
• 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.
• Determine the priority status of all samples in each day's lab batch and ensure the expedited processing of samples to meet the client's requirements.
• Develop, review, validate, and approve test methods, SOPs, and data sheets to ensure compliance with ISO and FDA requirements.
• Ensure each technician within their responsibility has undergone orientation and has sufficient knowledge for their safety and health while at work.
• 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.

Job Expectations

• The Employee is expected to dedicate the time necessary to accomplish the given job requirements.
• Strive to continuously build knowledge and skills and share expertise with others.
• Seek exposure to outside training opportunities and membership in at least one professional organization.
• Adherence to Berkshire's Code of Conduct and Professional Ethics Standards.

Physical Requirements

• Hands to finger, feel, and handle testing equipment and product; operate computer
• 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, smelling
• Close, peripheral and depth perception vision
• Quiet work environment
• Exposure to fumes or airborne particles and toxic or caustic chemicals
• Ability to gown per ISO Class 4 and 6 environments including smock, latex gloves, bonnet, mask

Benefits

• Medical Insurance
• Dental Insurance
• Vision 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
• Paid Vacation
• Personal/Sick
• 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