Quality Control (QC) Lab Support Associate

Quality Control (QC) Lab Support Associate needs 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering. Quality Control (QC) Lab Support Associate requires: • API (Active Pharmaceutical Ingredient) EM (External Manufacturing) Quality Assurance Associate ensures that third-party manufacturers (CMOs) produce medicine ingredients compliant with cGMP regulations and company standards • BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. • Must complete required training for API EM Quality Assurance. • Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. • Must be able to support 24 hour/day operations. • Up to 20% travel US & OUS. • Mail Admin Facility Clerk duties: • Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing. • Provide quality oversight of CM method validation or method transfer activities • Escalate quality issues at CMs to QA management. • Assist in the establishment and revisions of Quality Agreements with affiliates and customers. • Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).