Quality Specialist (Regulated Industry)

Reposted 21 Days Ago
Be an Early Applicant
Wilson, NC, USA
In-Office
Entry level
Consulting • Pharmaceutical
The Role
The Quality Specialist supports quality management initiatives by ensuring compliance with regulations, conducting training, writing procedures, and participating in audits.
Summary Generated by Built In

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

  1. Performs all functions listed below with direct supervision.
  2. Support to issue and solve internal corrective measures report.
  3. Ensure current service/product quality specification fulfill client’s requirements.
  4. Support Quality Management Systems operation within organization.
  5. Provide support for design, execution and maintenance of quality system processes at respective departments.
  6. Help department to coordinate training to operating procedure changes or new system implementation.
  7. Ensure operating procedures are of use to end users.
  8. Direct writing and review operating procedures (OP’s) to ensure compliance, efficiency and clarity.
  9. Participate in corrective action discussions as necessary.
  10. Revise department complaints and implement corrective actions for clarity and fullness in investigations.
  11. Comply all activities with MTG’s policies as well as departmental procedures to reduce risk and losses.
  12. Ensure program activities are in compliance with applicable government regulations and company quality assurance standards.
  13. Recommend, implement and direct others to modify operational methods and practices along with overall strategy to enhance department effectiveness.
  14. Support the Quality Manager in Client Internal Audits.
  15. Comply with the ISO Certifications ISO 9001 and ISO 17025.
  16. Prepare evaluation reports and submit them to Quality & Customer Service Manager.
  17. Function as an information source for bottlers and other departments when critical quality issues arise.
  18. Establish and manage professional customer rapport to drive solutions to attain business needs.
  19. Other responsibilities as assigned by supervisor/management.

Educational or Equivalent Requirements:
  • Degree in Engineering, Science, or related curriculum
  • Bachelor's Degree preferred

 

Top Skills

Iso 17025
Iso 9001
Quality Management Systems
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The Company
South San Francisco, CA
265 Employees
Year Founded: 2000

What We Do

MENTOR Technical Group is a team of highly educated, superior trained, and dedicated professionals with expertise and experience to provide a complete portfolio of technical support and solutions for the FDA-regulated industry. MENTOR Technical Group delivers solutions with a flexible cost-effective approach to meet your company’s needs. Our purpose is to help you bridge the gap between your business strategies and results, by balancing three major aspects: People, Regulatory and Compliance, and Technology. MENTOR Technical Group’s objective is to deliver reliable tailored solutions—from consultation to becoming part of your staff. This proximity helps us develop customized frameworks to help you unlock the hidden value in your plants, facilities, equipment, and staff, while optimally integrating resources, regulations, and technology. MENTOR Technical Group’s commitment begins by getting involved from the conceptual phase up to the implementation phase of your projects. Our management staff has unparalleled experience in both the operating and consulting industries. We have over 200 technical staff members, which allows for efficient project execution. At MENTOR Technical Group, we deliver on our commitments—every time, on time. Our enthusiastic highly skilled workforce consistently meets or exceeds client expectations. We don’t just perform for our clients; we work with integrity. Our professional staff takes pride in their work and acts with a sense of ownership.

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