503B Quality Assurance Associate II at The Ritedose Corporation in Columbia, South Carolina

Job Description:

The 503B Quality Assurance Associate II is responsible for review of batch records, qualifications, and protocols associated with 503B in accordance with applicable SOPs. 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:

• Copy and scan batch records and QMS documentation


• Batch record review for completeness, accuracy, and compliance to TRC standards and coordinate required corrections


• Verification of critical processing steps (dispensing, compounding, sterile transfer, visual inspection, etc.)


• Elevate deviations, IRs, OOS and other issues impacting quality to Direct Supervisor or other applicable parties


• Issue product Certificate of Analysis and upload batch trend data


• Create and revise Quality documents associated with 503B


• Track and 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

Qualifications:

• 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 written and oral communication skills