Compliance Specialist consultant

• Posted 3 days ago • Updated 1 hour ago
Contract W2
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Manufacturing
  • change control
  • Manufacturing Processes
  • Communication skills
  • Quality Management
  • Corrective and Preventive Action
  • Auditing Skills
  • Technical Writing Skills
  • Clinical Works
  • Knowledge of Packaging and Processing
  • Project Scoping
  • Content Creation
  • Complementary Metal-Oxide Semiconductor (CMOS)

Summary

Compliance Specialist consultant
12 Months
Location: Minneapolis, MN(Onsite)

Description

The company is growing is very quickly and this consultant is needed to support an increase in workload. The client outsources multiple functions to external partners for filling, packaging, etc. and also for drug substance, the Compliance Specialist needs to ensure anything coming from CMOs meets requirements or if anything needs to go through the Change Control process. The Consultant will need to be an expert working within Quality Systems as an owner of Change Control, Deviations, and CAPA records.

Project Scope:

  • Own and manage External Manufacturing items through Quality System including Change Control proposals, CAPAs, and SCARs for clinical and commercial external mfg.
  • Collaborate across the department and partner with External Manufacturing Operations relationship leads
  • Facilitate meetings to manage priorities and ensure current status updates
  • Contribute to improvements in External Manufacturing department SOPs. May lead reviews, audits for compliance, and revisions of SOPs

Top Requirements:

  • BS degree minimum
  • Minimum 5 years of experience working in Pharmaceutical industry
  • Strong communication and technical writing skills
  • Experience interacting with CMOs or other external groups like corporate partners, preferably in an External Manufacturing or QA role
  • Experience authoring, reviewing, or auditing operations against SOPs is preferred

    R. Divya Sri Sr. Technical Recruiter

    Address: 6110 McFarland St Dr, Alpharetta, GA 30004

    Contact + 1

    Email
    LinkedIn

    Website


Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91090330
  • Position Id: 2026-3867
  • Posted 3 days ago
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