QA Specialist
About the role
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)
- Capture and manage stability sample pulls, testing schedules, and sample inventory
- 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
- Absorb and assist in the investigations regarding customer complaints
- Participate in audits (as needed)
- Assist in performing corrective actions for audit findings
- Assist in the investigations regarding customer complaints
- Ensure new products and changes to existing products are carried out through the production process within the specification
- Absorb and assist in implementing procedures and specifications for Quality Control Inspectors and Quality Control Lab Technicians
Qualifications
- Two years of experience in medical devices, pharmaceuticals, manufacturing, or other related industries
- Microsoft Office competence
- Analytical skills
- Organizational skills
- Excellent written communication skills
- Interpersonal skills
- Keen attention to detail
- Critical/logical thinking
- Proficient in Microsoft Office Suite
Skills
- Quality System Implementation
- Product Stability Management
- Statistical Process Control
- Environmental Monitoring
- Stability Testing
- Regulatory Compliance
- Collaboration with Cross-functional Teams
- Customer Complaint Handling
- Corrective Action Planning
Benefits
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.