QA Specialist

SWM International; Knoxville (TN); On-site; USD 65,000 - 85,000; Full time

Job summary

Mativ Holdings, Inc. is seeking a quality stability professional to lead and monitor product stability programs in our manufacturing environment. You will implement stability protocols, coordinate samples, trend data, and ensure compliance with cGMP, FDA, and regulatory requirements.

You will collaborate with R&D, Quality Control, and Regulatory teams to maintain data integrity, prepare summaries for APR/PQR submissions, and support audits and investigations.

Qualifications

• Two years of experience in medical devices, pharmaceuticals, manufacturing, or related industries.
• Proficiency with Microsoft Office Suite.
• Strong documentation and record-keeping skills.

Responsibilities

• Responsible for the site equipment calibration and maintenance program.
• Ensures effective oversight of the product stability program, including monitoring, trending, and reporting stability data to support product quality, regulatory compliance, and lifecycle management.
• Own and oversee the site Product Stability Program in alignment with cGMP, FDA, and applicable regulatory requirements.
• Develop, maintain, and execute product stability protocols (initial, ongoing, and accelerated studies as applicable).
• Ensure stability studies are conducted within defined environmental conditions (temperature, humidity, light exposure where applicable).
• Coordinate stability sample pulls, testing schedules, and sample inventory management.
• Review and approve stability test results, ensuring compliance with predefined specifications and acceptance criteria.
• Perform statistical trending and analysis of stability data to identify adverse trends, shifts, or out-of-specification conditions.
• Lead stability-related investigations, including OOS, OOT, and atypical results.
• Assess the impact of stability results on product shelf life, expiration dates, and product quality.
• Generate stability summaries and reports for Annual Product Reviews (APR/PQR), regulatory submissions, and internal management review.
• Maintain stability chambers and ensure calibration, qualification, and monitoring of environmental conditions.
• Collaborate with R&D, Quality Control, and Regulatory teams on stability requirements for new products, product changes, and validations.
• Ensure data integrity, documentation accuracy, and audit readiness of all stability records.
• Work with manufacturing staff on quality-related issues.
• Assist with validations/product testing.
• Perform statistical process control and assist with verification of process control performed by others.
• Review cGMP documents to ensure company processes comply (DHRs, Batch Records).
• Monitor production practices to ensure compliance with the Quality Control procedure.
• Assist production staff where necessary regarding Quality Control procedures and issues.
• Complete documentation to show that tests have been carried out and recording whether the product met the standards or not.
• Compile test measurements and outcomes into reports for inclusion in Annual Product Reviews or Monthly Reports.
• Perform and assist in investigations regarding customer complaints.
• Participate in audits (as needed).
• Assist in performing corrective actions for audit findings.
• Ensure new products and changes to existing products are carried out through the production process within specification.
• Assist in implementing procedures and specifications for Quality Control Inspectors and Quality Control Lab Technicians.

Skills

Analytical skills

Microsoft Office

Attention to detail

Communication skills

Job description

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world.

This position will check the implementation of the quality system, conduct quality assurance audits, and monitor and record results of processes and procedures against manufacturing standards. Continually compares results to predetermined expected ranges and takes corrective measures if any deviation is found.

Responsibilities

• Responsible for the site equipment calibration and maintenance program
• Ensures effective oversight of the product stability program, including monitoring, trending, and reporting stability data to support product quality, regulatory compliance, and lifecycle management
• Own and oversee the site Product Stability Program in alignment with cGMP, FDA, and applicable regulatory requirements
• Develop, maintain, and execute product stability protocols (initial, ongoing, and accelerated studies as applicable)
• Ensure stability studies are conducted within defined environmental conditions (temperature, humidity, light exposure where applicable)
• Coordinate stability sample pulls, testing schedules, and sample inventory management
• Review and approve stability test results, ensuring compliance with predefined specifications and acceptance criteria
• Perform statistical trending and analysis of stability data to identify adverse trends, shifts, or out-of-specification conditions
• Lead stability-related investigations, including OOS, OOT, and atypical results
• Assess the impact of stability results on product shelf life, expiration dates, and product quality
• Generate stability summaries and reports for Annual Product Reviews (APR/PQR), regulatory submissions, and internal management review
• Maintain stability chambers and ensure calibration, qualification, and monitoring of environmental conditions
• Collaborate with R&D, Quality Control, and Regulatory teams on stability requirements for new products, product changes, and validations
• Ensure data integrity, documentation accuracy, and audit readiness of all stability records
• Work with manufacturing staff on quality-related issues
• Assist with validations/product testing
• Perform statistical process control and assist with verification of process control performed by others
• Review cGMP documents to ensure company processes comply (DHRs, Batch Records)
• Monitor production practices to ensure compliance with the Quality Control procedure
• Assist production staff where necessary regarding Quality Control procedures and issues
• Complete documentation to show that tests have been carried out and recording whether the product met the standards or not
• Compile test measurements and outcomes into reports for inclusion in Annual Product Reviews or Monthly Reports
• Perform and assist in investigations regarding customer complaints
• Participate in audits (as needed)
• Assist in performing corrective actions for audit findings
• Ensure new products and changes to existing products are carried out through the production process within specification
• Assist in implementing procedures and specifications for Quality Control Inspectors and Quality Control Lab Technicians

Qualifications

Required

• Two years of experience in medical devices, pharmaceuticals, manufacturing, or other related industries
• Microsoft Office competence

Preferred

• Analytical skills
• Organizational skills
• Excellent written communication skills
• Interpersonal skills
• Keen attention to detail
• Critical/logical thinking
• Proficient in Microsoft Office Suite

What We Offer

Mativ benefits say a lot about how we care for each other. Our employees and their families have many different needs. As a result, our benefits offer choices on many levels and are high in quality, competitive in the marketplace, and affordable.

About Mativ

Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company connects, protects, and purifies the world every day through a wide range of critical components and engineered solutions that solve our customers' most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company's two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers' products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.