Randstad Life Sciences US

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. Familiarity in Veeva systems or similar quality document management. Experience performing batch record review and batch disposition

distribution specialist

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

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