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Quality Systems & Distribution Specialist - REMOTE or Onsite

Randstad Life Sciences US
Portland, OR, United States
$35-$47 an hour
Remote
Full-time

Immediate opportunities for Quality Systems & Distribution Specialists to support the QA Central Services Team. Do you have a strong QA / GMP background to support with documentation release process, and working with CMOs / CDMOs?

This position is open to both REMOTE and onsite candidates. Apply today!

Schedule Shift : 1st shift, Wed.-Sat., 4x10 schedule, 8am-6pm (flexible). Additional OT may be needed on Sunday during July and August.

Position Type : Contract role for 6 mos. (through Dec 2024); extension possible up to 18 mos.

Pay Rate : $45-60 / hr. for Onsite and $35-$47 / hr. for Remote

Essential Duties and Responsibilities :

  • Perform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.
  • Conduct batch record review as needed
  • Administration support for documentation archive in Veeva eQMS
  • Ensure compliance with required training
  • Resolve issues with CMO documentation in collaboration with CS leads and CMO leads
  • Depending on skill set and previous experience, there may be need to rotate to support Compliance, operational excellence project work and / or quality project management teams.

Qualifications :

  • Sr. Specialist level (5+ years experience)
  • Excellent communication skills
  • Proficiency in regulatory requirements
  • Familiarity in Veeva systems or similar quality document management
  • Experience performing batch record review and batch disposition
  • Familiarity in Drug Product GMP Manufacturing
  • 14 days ago
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