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