Senior QA Associate
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POST DATE 9/4/2016
END DATE 11/6/2016
Revance Therapeutics, Inc.
JOB DESCRIPTIONAPPLY The role is an advanced level position with hands-on QA experience. Working independently and under minimal supervision, the individual will be working primarily in quality operations providing quality assurance support to CMC teams and to in-house DS and DP production and systems. In addition to batch record review, this candidate will be responsible for incoming QA, raw material disposition and the reserve sample program. The individual will be interacting with cross-functional groups such as Materials Management, Quality Control, Clinical Packaging & Labeling and Manufacturing.
Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development
Perform incoming quality attribute inspections; review and disposition incoming raw materials (e.g., chemicals, packaging and labeling components, etc.)
Perform retain sampling and maintain the reserve sample program
Perform line clearance and product inspection
Perform product complaints investigations
Review documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, specifications, stability protocols and reports, and method validation protocols and reports
Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release for drug substance, drug product, and clinical trial material
Act as a compliance resource to provide guidance and assistance towards resolution of moderate deviations, quality investigations, lab investigations, CAPAs and change controls; review and may approve quality system documents related to manufactured products
Support continuous improvement of quality operations processes; author new or revise existing department procedures and/or forms
Assist in internal compliance audits as needed
Provide inspection readiness support and assist during inspections by regulatory authorities
May support quality systems as needed (e.g., issue and track closure to change controls, deviations, quality investigations and CAPAs)