Quality Assurance Associate II
The Ritedose Corporation
Columbia, SC
quality assurance
assurance
trc
compliance
quality assurance
assurance
qa
cgmp
operations
team
written
training
document review
May 4, 2024
The Ritedose Corporation
Columbia, SC
FULL_TIME
The Quality Assurance Associate II is responsible for maintaining all training of a QAA I in addition to the review of controlled documents (both executed and unexecuted) in accordance with applicable SOPs. The QA Associate II will document review activities and status in the applicable Quality Systems. The purpose of QA review is to ensure the document, product, or process under assessment is compliant with all TRC, customer, and regulatory agency requirements.
Responsibilities:
Batch record review for completeness, accuracy, and compliance to TRC standards
Verification of critical processing steps (sterilization cycles, mix times, machine settings, etc.)
Track the number of corrections made in batch records
Issue product Certificate of Analysis or Conformance
Review of QMS documentation for compliance to SOPs, Work Instructions, and CGMP requirements
Manufacturing operations including supply chain, dispensing, compounding, filling, packaging, maintenance, and utilities
Quality operations including process control, quality control, quality assurance, compliance, and audit
Product labeling
Track/trend the batch record review process- identify and initiate improvements to process
Perform Product Complaint batch record review
Maintain a professional team-oriented working relationship with fellow employees
Follow written and verbal procedures as directed by Supervisor
Follow TRC SOPs, safety and health guidelines and cGMP guidelines
Minimum of Associates degree with 1 year of relevant experience, Bachelors degree, or 3 years relevant experience
Proficient with current word processing, spreadsheets, and database software
A high level of integrity and attention to detail
Ability to work independently as well as to participate in and contribute to a team-oriented work environment by developing positive working relationships within Quality and between other departments
Ability to handle and establish multiple priorities and meet expectations with minimal supervision
Strong oral and written communication skills
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