Job Description

Quality Assurance Specialist – Plymouth, MN

The role is responsible for providing Quality Assurance support and collaborates closely with other departments on investigations and Corrective Action Preventative Action (CAPA). It also involves assisting in regulatory, customer, and certification audits, as well as data collection and participating in external and internal audits.

Responsibilities:

• Facilitate annual GMP training alongside department liaisons.
• Investigate and communicate customer complaint resolutions.
• Conduct monthly facility walkthroughs and report findings.
• Address process failures via the company deviation process.
• Oversee the internal audit program, ensuring documentation, procedures, data, facilities, and systems comply with dietary supplement regulations (CFR Title 21, Part 111, NSF/ANSI 173-2003).
• Promote Safety policies and address/report hazards.
• Ensure timely review/closure of open CAPAs.
• Act as back-up contact for the Gluten Intolerance Group (GFCO).
• Aid in regulatory, customer, and certification audits.
• Handle responses to customer quality questionnaires.
• Support departments in quality-related initiatives.
• Communicate with clients regarding contract manufacturing.
• Assist clients with HACCP activities.
• Track and monitor quality system metrics.
• Help resolve record-related issues across departments, offering clarification and guidance.
• Contribute to documentation and data collection for annual product reviews.
• Provide back-up for line audits and document control.
• Undertake additional duties as assigned by Quality management.

Education / Experience / Certifications:

• Bachelor’s degree in Chemistry or a related scientific field required.
• Over 3 years of experience in quality assurance within the pharmaceutical, food, or dietary supplement industry.
• Proficient in conducting internal audits and handling investigations/CAPAs.
• Strong oral and written communication skills for fostering effective collaboration across departments.
• Familiarity with quality standards, GMP, FDA regulations, and CFR Title 21, Parts 111, 210, or 211.
• Demonstrated strengths in mathematics, analytical thinking, and problem-solving.
• Capable of maintaining documentation that is accurate, clear, and comprehensive.
• Skilled at managing multiple priorities efficiently without compromising quality.
• Proficiency in reading and writing English.
• Driven, proactive, and eager to coach and mentor colleagues at all organizational levels.

Details:

Direct Hire

Salary commensurate with experience (starting at $70,000/year) and Benefits

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