Logistics of the Role:
Requirements:
Preferred:
Job Description: One of our large pharmaceutical clients is looking to hire a remote Quality Specialist to join the EQ team. The individual will provide QA support for External Manufacturers of biotherapeutic Drug Substance (API) and parenteral Finished Product. They will perform assigned duties and collaborate with cross-functional teams to maintain regulatory standards, facilitate communication within the core team, and help to ensure that all quality-related activities project goals and deadlines are met. This individual will be required to travel to EM sites up to 1x-2x per month.
In particular, the specific tasks required on a daily basis by the position are:
Support, review/pre-review, and/or approve the following -
-Batch record review
-Quarantine shipment (Q-ship) activities
-Release for Further Processing (RFFP) activities
-EM Quality Events
-EM CAPAs
-EM Change Controls
-EM Planned Deviations
-EM Product Quality Complaints
-EM Protocols
-EM Risk Assessments
-EM Electronic Batch Record (eBR) changes
-EM Manufacturing Process Instruction (MPI) changes
-EM equipment specific Master Validation Plan (MVP) changes
-New equipment qualification documentation
Own/support the following
- Own and execute change control activities
-Own/support internal Nonconformances (NC) in Comet
-Own/support internal Investigations in Comet
-Own/support internal Supplier Investigations in Comet
Help maintain/manage/keep organized the following
-Outstanding EM issues
-Transfer of document to the EM
-Status of lots/production schedule
-Various workstreams (help build templates, flowcharts, etc.)
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