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.
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
-Sterilization-specific documentation
-New equipment qualification documentation

Own/support the following
-Own Child records for Change Controls in TrackWise
-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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