A client of Sharp Decisions Inc. is looking to bring on a Pharmaceutical QA Specialist to be based in Frederick, MD . This position is 100% onsite .

The duration is 12 months with a possible extension. *W2 and Local only

Pay - $43/hour on W2

Job description

As a member of the Operations and Compliance Support team, you will be part of a team of investigators responsible for the examination and resolution of adverse events (quality events) that occur within manufacturing operations for engineered T-Cell therapy products at the Frederick, Maryland site.

Responsibilities Include (but are not limited to):

• Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements.
• Initiate quality records in the Veeva Quality Management System (QMS).
• Lead cross-function team meetings to perform complex root cause analysis (RCA).
• Compile investigation results in a concise and comprehensive technical report format.
• Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).
• Manage investigation timelines to meet/exceed site compliance metrics for closure adherence.
• Provide timely progress updates to internal stakeholders, as required.

Basic Qualifications:

• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience or
• AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience or
• HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent

Preferred Qualifications:

• Strong skill in technical writing
• Strong skill in organization
• Strong skill in root cause analysis
• Experience in cell culture or aseptic processing
• Experience in cGMP cell therapy manufacturing