Main Purpose:
The Quality Assurance Associate I (QAA I) is responsible for overseeing and implementing the Quality Management System (QMS), Standard Operating Procedures (SOPs), processes, and policies for the Storage, Distribution, Transportation, and Kit Production Facility. The QAA I ensures compliance with regional and local regulations, customer requirements, and standards such as GMP, GDP, GSP, ISO 13485, and ISO 9001.

Main Duties and Responsibilities:

1. Implement, communicate, and maintain the company's quality systems at the facility in compliance with the Global Quality Management System (QMS) requirements.
2. Interact with clients on Quality Assurance (QA)/GxP-related matters under management supervision.
3. Collaborate with various departments and stakeholders to ensure all QA tasks are adequately supported.
4. Support internal audits, including report preparation and tracking of corrective and preventive actions (CAPA).
5. Assist in auditing external service providers as part of the vendor selection process and track commitments for actions from previous audits.
6. Support client audits and regulatory inspections, including preparing necessary materials.
7. Collect and analyze issues, CAPA, Risk Assessment, Change control, and training metrics to identify quality improvement initiatives.
8. Identify and deliver relevant GxP/Quality-related training.
9. Ensure the Quality System and GxP Program are implemented and maintained.
10. Assist in evaluating designated vendors and/or outsourced activities.
11. Ensure the accuracy and quality of records and documents.
12. Actively participate in internal Quality and designated meetings.

Facility-Specific Duties (if applicable):

1. Perform QA visual/physical inspections of pharmaceutical products according to internal procedures and client requirements.
2. Review and release incoming material receipts per relevant SOPs.
3. Verify and approve label printing processes and additional labeling/repackaging activities.
4. Perform QA activities required for warehouse movement and inventory status control.

General:

1. Perform activities assigned by QA Management.
2. Travel as reasonably requested by the Line Manager.

Support timely and effective communication and escalation of quality issues to the appropriate management levels.

Ascendo is a certified minority owned staffing firm, and we welcome and celebrate diversity. Ascendo is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, parental status, military service or any other characteristic protected by federal, state or local law.

Contact information

Nicholas Cretella