Quality Assurance Associate Ii

Job Description
Supports all Quality Assurance I roles as required
Supports administrative function by:
Monitoring quality systems deadlines and reports to management pending and overdue activities
Assisting in Analytical Subcontractor documentation maintenance
Assisting with writing, reviewing, and approving Events, CAPA, OOS/OOT, and Change Control
Writing, reviewing, and conducting Quality System, cGMP, and GLP training as required
Supports Data Reporting by:
Reviewing, approving, and releasing laboratory data
Reviewing, creating, and approving Certificates of Analysis
Reviewing and approving Cumulative Reports, Protocols, Technical Reports and Summaries
Reviewing and approving Methods
Supports Document Control by:
All Quality Assurance I roles
Maintaining all Master Lists
Maintaining Control of Specifications
Assisting with writing and approving internal documents
Supports Equipment Control by:
Maintaining identification and calibration labels/cards
Reviewing and approving of preventative maintenance, verification, calibration, and qualification
Maintaining records in LIMS
Induction and decommissioning
Supports Auditing by:
Performing Internal audits per Standard Operating Procedure
Supporting client and regulatory audits as needed
Supports Stability as needed by:
Reviewing and approving Stability Protocols
Reviewing Stability Chamber Pull Schedules
Reviewing and approving Stability Chamber mapping
Monitoring and following up Stability Chamber excursions
Supports Manufacturing as needed by:
Executing and reviewing batch records
Quality Assurance inspection and release of cGMP materials
Other functions as assigned