Quality Assurance Specialist Job at Kelly Science, Engineering, Technology & Telecom, Plymouth, MN

NnNIUGhaS1lNYm1RWnB4K2dtVGRnejVST3c9PQ==
  • Kelly Science, Engineering, Technology & Telecom
  • Plymouth, MN

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

Job Tags

Contract work,

Similar Jobs

NTD

Video Photojournalist Job at NTD

The Epoch Times's sister media, NTD DC Bureau, is seeking a skilled and experienced photojournalist to join our team and cover news events, both live and recorded, around Washington, DC, including Capitol Hill, the White House, and various other government agencies. ...

Stratton Mountain

HVAC/R Technician Job at Stratton Mountain

 ...Additional perks & benefits for year round employees POSITION SUMMARY The HVAC/R Professional will coordinate and execute all HAVC/R improvements, repairs and preventative maintenance requirements for resort facilities. This position may also require the supervision... 

Ryan Consulting Group, LLC

Instructional Designer Job at Ryan Consulting Group, LLC

 ...initiatives. This role is key to improving performance and enhancing the skills of our support team through the design, delivery, and evaluation of impactful learning program s. Key Responsibiliti es:Design and deliver engaging instructor-led and virtual training... 

REACH Medical Holdings

Helicopter Pilot SPIFR - Fire Base Job at REACH Medical Holdings

 ...Retention Bonus Plan) The Lead Pilot is a key member of our operational leadership team, responsible for overseeing daily pilot...  ...pilots, and acts as a liaison between pilots, base leadership, and flight operations management. This role requires strong leadership... 

Association for the Advancement of Medical Instrumentation

Marketing & Communications Manager Job at Association for the Advancement of Medical Instrumentation

 ...the worlds leading organization for advancing the development, management, and use of safe and effective healthcare technology. AAMI...  ...future of health technology. AAMI is seeking a full-time Marketing & Communications Manager ; Qualified applicants should send their...