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