Associate, QA Compliance

Jubilant Bhartia Group•Spokane, WA

47d•$31 - $42•Onsite

About The Position

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.

Requirements

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
Minimum 2 years of experience required. Bachelor's degree can be used in lieu of experience.
Microsoft Word & Excel experience required.
Knowledge of cGMPs desired.

Nice To Haves

Bachelor's Degree in a science field desired.
Sologic Certificate desired
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.

Responsibilities

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.