Quality Control 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).