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.

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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).