Description:
The QA Compliance Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities.
- Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
- Accountable for facilitating Deviations investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
- Enters data into database in support of the corporate RCA and CAPA activities.
- Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks.
- Interface with management and responsible individuals to assure task completion on or before established due dates.
- Responsible for supporting quality systems, processes and procedures (e.g. Deviations, CAPA, Vendor complaint, etc…) to assure compliance and product quality and safety.
- Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
- Provide Deviations and CAPA metrics as needed in support of management review of system data.
- Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
Qualifications:
- Associates Degree in Biology, Chemistry or related field required.
- 5 years of experience may be used in a lieu of an Associate’s degree required
- Bachelor’s Degree in a science field desired.
- Sologic Certificate desired
- Minimum 2 years of experience required. Bachelor’s degree can be used in lieu of experience.
- Pharmaceutical and FDA regulated industry experience desired.
- Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired.
- Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
- Microsoft Word & Excel experience required.
- Knowledge of cGMPs desired.