Quality Control Manager

Human Resources•Whitsett, NC

141d

About The Position

The Quality Control Manager oversees all QC laboratory operations, including receiving, in-process, and finished-goods testing across nonwoven, knitted, and textile materials; chemical products; and sterile and cleanroom products. The role ensures compliance with ISO 9001, ISO 22716, ISO 13485, FDA 21 CFR Part 820, GMP, GDP, and data-integrity requirements. The manager leads laboratory personnel, supports manufacturing and product development, and ensures testing conforms to internal, customer, and regulatory specifications. The position calls for a proactive, detail-oriented professional with integrity, a positive and solution-focused approach, and the ability to work independently and collaboratively. The manager responds appropriately to production and customer needs and maintains professional relationships with colleagues, vendors, and suppliers. The role also supports audits, CAPA, change control, investigations, production troubleshooting, and product and process improvement. It includes oversight of laboratory equipment, methods, records, supplies, chemical handling, testing priorities, and staff safety and development. The position reports to the Quality Director, who may also assign other duties.

Requirements

Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or another related discipline.
At least 6 years of QC experience.
At least 4 years of leadership experience.
Proficiency in Microsoft Office, ERP, and LIMS systems.
Attention to detail and commitment to compliance.
Ability to independently make decisions and lead a department of laboratory technicians.
Ability to multitask and maintain excellent organizational skills.
Excellent interpersonal and leadership skills, including the ability to develop, mentor, and coach staff.
Ability to use advanced mathematics with specifications, charts, tables, and handbook formulas for presentations.
Ability to solve problems requiring multiple steps of logic and calculation.
Ability to use judgment to analyze facts and circumstances and determine action within standard or accepted practice.
Ability to interpret written, oral, diagrammatic, or schedule-form instructions, including complex conditional instructions.
Ability to apply technical terms and jargon to stated situations.
Ability to use precision measuring instruments, laboratory equipment, and personal computers to input data.
Ability to read and comprehend written instructions.
Ability to handle testing equipment and products, operate a computer, and meet the stated physical and cleanroom-gowning requirements.
Ability to work near moving mechanical parts and in settings involving fumes or airborne particles and toxic or caustic chemicals.

Nice To Haves

Experience in textiles, nonwovens, or knitted materials.
Experience in controlled cleanroom and sterile manufacturing environments.
Experience in regulated industries, including medical-device or cosmetic GMP-regulated environments.
Exposure to outside training opportunities and membership in at least one professional organization.

Responsibilities

Supervise, lead, train, and maintain staffing coverage for laboratory personnel in line with production and QC needs.
Conduct performance evaluations and develop employees’ knowledge, skills, and abilities.
Ensure laboratory compliance with ISO 9001, ISO 22716, ISO 13485, FDA 21 CFR Part 820, and applicable equipment-calibration and process-control requirements.
Maintain laboratory records, audit laboratory data, 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 and participate in group and project meetings.
Ensure routine quality assurance and quality control testing and inspection of manufactured products to verify conformance to specifications.
Oversee test results and analysis for product-development samples and samples submitted by overseas affiliates.
Prepare reports, graphs, and charts as required.
Use statistical techniques to identify adverse data trends and outliers, in partnership with the Quality Manager.
Ensure laboratory equipment is calibrated and perform routine equipment maintenance.
Prioritize samples in daily lab batches and ensure expedited processing when needed to meet client requirements.
Develop, review, validate, and approve test methods, SOPs, and data sheets for compliance with ISO and FDA requirements.
Ensure technicians receive orientation and have adequate knowledge, information, resources, and materials to work safely; ensure safety protocols are followed.
Maintain appropriate laboratory supply levels by tracking inventory, placing orders, and verifying receipt.
Ensure the team follows internal standards, policies, and procedures.
Partner with Quality Assurance on applicable compliance activities, including certificates, photos, and environmental monitoring.
Partner with the Chemical Hygiene Officer to manage laboratory chemicals, storage, and proper disposal.
Assist with the Non-Conforming Material Process, including reporting and sampling.
Assist in troubleshooting production problems and in process/product improvement and development.
Provide customers and other visitors with tours and overviews of the QC laboratory process.
Oversee laboratory testing and preparation of chemical solutions according to standard formulae.
Perform other duties assigned by the Quality Director.
Dedicate the time necessary to accomplish job requirements, continuously build and share knowledge and skills, seek outside training and membership in at least one professional organization, and adhere to Berkshire’s Code of Conduct and Professional Ethics Standards.