Lead Associate, QA Compliance- Nights

Jubilant Bhartia Group•Spokane, WA

43d•$77,969 - $101,200•Onsite

About The Position

The QA Compliance lead 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.

Requirements

Associates Degree in Biology, Chemistry or related field required.
5 to 10 years related experience required with an Associate's Degree required.
Minimum of 3 years related experience required with a Bachelor's Degree required
Pharmaceutical and FDA Regulated Experience required.
Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
Ability to lift 30 pounds unassisted required
Microsoft Word & Excel experience required
Knowledge of cGMPs desired
Prolonged sitting required

Nice To Haves

Bachelor's Degree in a science field desired.
Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
Lead and Supervisory 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.
Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
Speak to deviations during regulatory and client audits.
Assist with reviews and approval of minor deviations in the QMS system.
Assist with extension requests approvals when permitted by procedure.
Assist with RCA chart review for the QAC team members.
Act as QA SME on Change Control records within the QMS.
Provide leadership and guidance to QAC team members.
Report performance issues to QAC supervisor as they arise.
Act as the QA Compliance Supervisor when requested by the QA Manager. (In the absence of the supervisor)