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Jubilant Pharma Limited · 1 day ago

Lead Associate, QA Compliance

Spokane, WA

Full-time

Onsite

Mid, Senior Level

$78K/yr - $101K/yr

5+ years exp

Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The QA Compliance Lead Associate is responsible for supporting the company's Deviations and CAPA program, ensuring product compliance and safety, and overseeing quality systems related to these activities.

Health CareManufacturingPharmaceutical

Responsibilities

Provide 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

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

Qualification

Pharmaceutical ExperienceFDA RegulationsCAPA SystemRoot Cause AnalysisTechnical WritingSupervisory SkillsAseptic ManufacturingQuality Assurance OperationsQuality Control AnalysisLeadership

Required

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

Prolonged sitting required

Preferred

Bachelor's Degree in a science field desired

Direct or supporting aseptic manufacturing experience in bio/pharma industry desired

Lead and Supervisory desired

Benefits

Medical, Dental, Vision, Flexible Spending and Health Savings Accounts

Life, AD&D, Short and Long Term Disability

401(k) with company match

Generous paid time off plan

Employee Assistance Program

Company

Jubilant Pharma Limited

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to our customers across geographies.

Founded in 2014

Singapore, Central Region, SGP

1001-5000 employees