Quality Systems and Compliance Contractor

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Quality Systems and Compliance Contractor

Cambridge, Massachusetts

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Full Time Temporary/Contract

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$ 50 - $ 70 per hour

Cambridge, Massachusetts

Full Time Temporary/Contract

$ 50 - $ 70 per hour

September 26, 2024

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Job ID: 1392589_1727355040

September 26, 2024

Job ID: 1392589_1727355040

Job Summary

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Quality Systems and Compliance Contractor

Duties:

Management in product complaint handling including but not limited to:

  • Intake of Product Complaints from the secured access mailbox
  • Perform weekly and monthly product complaint reconciliations with vendors, partners, affiliates and Drug Safety & Pharmacovigilance
  • Assist in providing product complaint metrics reports
  • Develop training on product complaint handling
  • Assist with revision of product complaint SOPs
  • Archive product complaints in accordance with policies
  • Act as a QS&C document control back-up support
  • Will support regulatory inspection preparation and onsite during inspections as required.
  • This position will be a hybrid role including both remote and onsite days

Skills

  • Prior Experience in management of product complaints and/or adverse event process, intake, reconciliations, etc.
  • Experience with GxP regulations including but not limited to product complaint handling, patient privacy principles, document control, etc.
  • Experience with Veeva QualityDocs and Veeva eQMS a plus
  • Education: B.S. degree in life sciences, chemistry or engineering or equivalent and a minimum of 5 years experience in Pharmaceutical Quality or Regulatory
1392589_1727355040

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™