Quality Assurance Specialist

Berkshire is the global contamination control leader for clean room 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 55 years Berkshire has understood and delivered world class manufacturing, reliable supply chain, highest standards for quality, technically advanced products assuring mutual success each step of the way. The ideal candidate will be strategic minded, be a team player that can also work independently with a positive attitude, be proactive, manage complex tasks and problem solve, and possess a high attention to detail. The Quality Assurance Specialist must have the ability to collaborate with peers and management and demonstrate exceptional judgement and a high degree of professional maturity while modeling loyalty, integrity, and honesty. Key Job Functions: 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 with internal reporting and audits. Collect, analyze, and visualize quality data graphically for quality reporting. Create certificates for all products. Receiving, in-process, and final inspections. Description of Candidate: Demonstrate integrity and professionalism. Demonstrate a positive attitude in the face of challenges. Maintain a professional demeanor both internally and externally with vendors, customers, 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 communicate and work well with all levels of the organization. Ability to perform responsibilities with minimal supervision. Ability to assist with IQ/OQ/PQ validations. Ability to maintain confidentiality in matters involving security and/or manufacturing. Willingness and ability to remain current in skills and industry trends. Qualifications of Candidate: Bachelor’s Degree from an accredited college or university or three to five years’ related experience and/or training; or equivalent combination of both. Excellent organizational skills. Knowledge and experience with Six Sigma and Root Cause Analysis. Ability to effectively prepare and present information in on-on-one and small group situations. 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. Use of mathematics together with the use of drawings, specifications, charts, tables. Good working knowledge of MS Office and ERP system software; LIMS/QMS experience desirable. Ability to use precision measuring instruments including equipment and personal computer to input data. Excellent analytical, problem-solving, and decision-making skills. Proficiency in best practices for testing, version control, and defect management. Environmental monitoring experience (air, water, surface, and personnel). Textile industry (knitting, finishing, yarns), Knits and Non Wovens experience. Previous experience with ISO 9001 system in manufacturing environment. Cleanroom experience (ISO Class 4-8) a plus. Job Description: Maintain the company’s 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 all records associated with the Quality Department both written and electronically. Review purchased products or components according to inspections plans; provide input to the acceptance of product and future purchases from suppliers. Document data obtained during all quality assurance activities, consistent with company policies and procedures. Communicate significant issues or developments identified during quality assurance activities and provide recommended process improvement to management. Effectively prepare reports to communicate involvement and results of quality assurance activities. Effectively prepare and present technical and program information to team members and management. Maintain a working knowledge of government and industry quality assurance codes and standards. Generate purchase orders, prepare, and send out product for 3 rd party testing. Obtain and distribute test reports as required by internal personnel and customers. Review sterility documentation, generate batch reports, and Certificates of Sterility. Prepare Certificates of Conformance and Certificates of Analysis for customers upon request or as required by customer agreements. Handle product returns process. Assist in the preparation, revision, and distribution of ISO documentation; assist in scheduling internal audits and ensure they are being done as scheduled, assisting internal auditors as needed; assist in preparation of 3 rd party audits. Initiate and monitor Non-Conforming Material and Corrective/Preventive Action processes in NC. Monitor existing processes and develop alternatives/improvements to drive efficiencies, ensure quality and on time delivery, and remove waste. Utilize techniques such as Lean, Six Sigma, Root Cause Analysis. Work with department leaders to identify areas of their operations where kaizen activities and Six Sigma will improve operating efficiencies, flow, inventory levels, and manufacturing costs. Other duties as assigned by Quality Supervisor and/or Quality Manager. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Job Expectations: The Employee is expected to dedicate the time necessary to accomplish the given job requirements. This position requires 40+ hours per week with the ability and willingness to work overtime during the week and Saturdays; ability to work flexible hours between 6am-6pm, for production run purposes. 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, walking, sitting, reaching with hands and arms. Occasional lifting and moving of up to 25 lbs. Occasional climbing, balancing, stooping, crouching, crawling, smelling. Close, peripheral and depth perception vision. Moderate noise work environment. Occasional work in non-temperature-controlled warehouse environment. Ability to gown per ISO Class 7, 4 and 6 environments as needed. Benefits Medical Insurance Dental Insurance Vision Insurance Life Insurance 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 job. An Equal Opportunity Employer www.berkshire.com