Quality Assurance Associate

THE RITEDOSE CORPORATION•Columbia, SC

2d•$27 - $27•Onsite

About The Position

The Quality Assurance Associate II maintains all training of a QAA I and reviews controlled documents, both executed and unexecuted, in accordance with applicable SOPs. The associate documents review activities and status in applicable Quality Systems. The purpose of QA review is to ensure that documents, products, and processes under assessment comply with TRC, customer, and regulatory agency requirements.

Requirements

An associate degree and one year of relevant experience, a bachelor's degree, or three years of relevant experience.
Proficiency with current word processing, spreadsheet, and database software.
High integrity and attention to detail.
Ability to work independently and contribute to a team-oriented work environment by developing positive working relationships within Quality and across other departments.
Ability to handle and establish multiple priorities and meet expectations with minimal supervision.
Strong oral and written communication skills.

Responsibilities

Review batch records for completeness, accuracy, and compliance with TRC standards.
Verify critical processing steps, including sterilization cycles, mix times, and machine settings.
Track the number of corrections made in batch records.
Issue product Certificates of Analysis or Conformance.
Review QMS documentation for compliance with SOPs, Work Instructions, and CGMP requirements.
Review manufacturing operations, including supply chain, dispensing, compounding, filling, packaging, maintenance, and utilities.
Review quality operations, including process control, quality control, quality assurance, compliance, and audit.
Review product labeling.
Track and trend the batch record review process, identify improvements, and initiate them.
Perform batch record reviews for product complaints.
Maintain professional, team-oriented working relationships with fellow employees.
Follow written and verbal procedures as directed by the Supervisor.
Follow TRC SOPs, safety and health guidelines, and cGMP guidelines.