Quality Systems & Distribution Specialist - REMOTE or Onsite

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