Quality Assurance Specialist

Berkshire•Whitsett, NC

10d

About The Position

Berkshire is hiring a Quality Assurance Specialist to maintain quality inspection and product-release programs for incoming and in-process materials, components, processes, finished goods, and product returns. The role plans and oversees inspection and testing for quality and conformance to specifications, maintains quality records, documents and reports quality activities, and communicates issues and recommended process improvements to management. It also supports supplier product review, third-party testing, product returns, sterility documentation, customer certificates, ISO documentation and audits, and nonconforming-material and corrective/preventive-action processes. The specialist works with department leaders to identify process improvements and use Lean, Six Sigma, root-cause analysis, kaizen, and related approaches to improve efficiency, quality, delivery, flow, inventory, and manufacturing costs. The role requires collaboration across organizational levels, professional judgment, attention to detail, integrity, and the ability to work independently with minimal supervision. The position requires 40 or more hours per week, with willingness and ability to work weekday overtime and Saturdays and flexible hours between 6 a.m. and 6 p.m. for production runs.

Requirements

Bachelor’s degree from an accredited college or university, or three to five years of related experience and/or training, or an equivalent combination.
Excellent organizational skills and attention to detail.
Knowledge and experience with Six Sigma and root-cause analysis.
Ability to prepare and present information effectively in one-on-one and small-group situations.
Ability to interpret written, oral, diagrammatic, and schedule-form instructions, including complex instructions with conditional requirements.
Ability to use mathematics and drawings, specifications, charts, and tables.
Good working knowledge of MS Office and ERP system software.
Ability to use precision measuring instruments and a personal computer to input data.
Excellent analytical, problem-solving, and decision-making skills.
Proficiency in testing, version control, and defect-management best practices.
Environmental monitoring experience, including air, water, surfaces, and personnel.
Previous experience with an ISO 9001 system in a manufacturing environment.
Demonstrated integrity, professionalism, positive attitude, sound judgment, and professional maturity.
Ability to work independently and collaboratively, communicate with all organizational levels, respond urgently to production and customer needs, and perform with minimal supervision.
Ability to maintain confidentiality in matters involving security and manufacturing and remain current in skills and industry trends.
Ability and willingness to dedicate the time needed to meet job requirements, work 40 or more hours per week, work overtime during the week and on Saturdays, and work flexible hours between 6 a.m. and 6 p.m. for production runs.
Ability to gown for ISO Class 7, 4, and 6 environments as needed.

Nice To Haves

LIMS/QMS experience.
Experience in the textile industry, including knitting, finishing, or yarns; experience with knits and nonwovens.
Cleanroom experience in ISO Class 4–8 environments.

Responsibilities

Interpret, build upon, and comply with company quality assurance standards.
Maintain complaint and nonconformance processing through records and tracking systems, including root-cause analysis and corrective actions.
Document quality assurance activities through internal reporting and audits; collect, analyze, and graphically present quality data.
Create certificates for products and perform receiving, in-process, and final inspections.
Maintain quality inspection and product-release programs for incoming and in-process materials, components, processes, finished goods, and product returns.
Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables.
File and maintain written and electronic records associated with the Quality Department.
Review purchased products and components according to inspection plans and provide input on product acceptance and future supplier purchases.
Communicate significant issues or developments identified during quality activities and recommend process improvements to management.
Prepare reports and present technical and program information to team members and management.
Maintain working knowledge of government and industry quality assurance codes and standards.
Generate purchase orders, send products for third-party testing, and obtain and distribute test reports.
Review sterility documentation, generate batch reports and Certificates of Sterility, and prepare Certificates of Conformance and Certificates of Analysis as requested or required by customer agreements.
Handle product returns.
Assist with preparation, revision, and distribution of ISO documentation; schedule and support internal audits and assist with third-party audits.
Initiate and monitor Non-Conforming Material and Corrective/Preventive Action processes.
Monitor existing processes and develop improvements to increase efficiency, quality, and on-time delivery and reduce waste.
Work with department leaders to identify kaizen and Six Sigma opportunities to improve operating efficiency, flow, inventory levels, and manufacturing costs.
Assist with IQ/OQ/PQ validations.
Perform other duties assigned by the Quality Supervisor and/or Quality Manager.