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