Quality Assurance Specialist role at MilliporeSigma (Merck Group) in Bellefonte, PA, focused on maintaining and improving site quality systems and regulatory/ISO compliance across production and lab operations. You’ll handle audits, batch record review, change control, validations, complaint investigations, and quality metrics trending. Standout perk: comprehensive benefits including health insurance, PTO, and retirement contributions (plus potential bonus eligibility).
- Health insurance, PTO, retirement contributions
- Bonus eligibility (role dependent)
- Inclusive, growth-focused culture
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Quality Assurance Specialist in Bellefonte, PA ensures that all aspects of product and service meet quality standards. Job duties include:
- Support the site's quality management system, ISO accreditations, and regulatory compliance by executing internal/external audits, changing controls, validations, document control, and customer complaint investigations.
- Review completed batch records for compliance and execute the Management of Change (MOC) process for quality-related modifications to documents, equipment, specifications, and methods.
- Participate in internal and supplier audit programs by issuing post-audit reports, maintaining the customer audit database, and tracking corrective actions through to final effectiveness checks.
- Monitor and trend critical quality metrics-including pass rates and customer complaints-while directly responding to client inquiries and managing quality-related customer ratings.
- Write and/or review documentation to ensure compliance to all standards or regulations
- Coordinate site validation activities and provide strategic oversight to the calibration department to ensure continuous equipment compliance.
- Engage regularly with production and laboratory personnel to ensure seamless communication of quality services, while leading root cause analyses and risk assessments for process and product investigations.
- Lead process improvement projects within the document control system to drive operational efficiencies, while continuously updating and optimizing departmental quality metrics.
- Coordinate the design and execution of quality training programs to support continuous employee development and maintain site-wide regulatory compliance.
- Maintain the quality actions and look for trends
- 5% travel anticipated
Who You Are
Minimum Qualifications:
- Bachelor's Degree in Chemistry, Biochemistry, or other science fields OR Quality Assurance
- 2 + years of quality experience
- 1 + years of experience working on or leading process improvement projects
Preferred Qualifications:
- Knowledge of ISO quality management system
- Demonstrate exceptional analytical and organizational skills to prioritize complex workflows, master new concepts rapidly, and utilize advanced computer software (MS Excel, Word, and databases) while maintaining strong interpersonal collaboration.
RSREMD
Pay Range for this position: $70,600.00 - $111,000.00.
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!