Job Title

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: $45-60hr. for Onsite and $35-$47hr. for RemoteEssential Duties and Responsibilities:Perform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.Conduct batch record review as neededAdministration support for documentation archive in Veeva eQMSEnsure compliance with required trainingResolve issues with CMO documentation in collaboration with CS leads and CMO leadsDepending on skill set and previous experience, there may be need to rotate to support Compliance, operational excellence project work andor quality project management teams.Qualifications:Sr. Specialist level (5+ years experience)Excellent communication skillsProficiency in regulatory requirementsFamiliarity in Veeva systems or similar quality document managementExperience performing batch record review and batch dispositionFamiliarity in Drug Product GMP Manufacturing