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Jubilant Pharma Limited · 17 hours ago

Associate, QA Compliance - Weekend Nights

Spokane, WA

Full-time

Onsite

Entry, Mid Level

$30.99/hr - $41.93/hr

2+ 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 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.

Health CareManufacturingPharmaceutical

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

Qualification

Pharmaceutical industry experienceCAPA systemsTechnical writingSologic CertificateCGMP knowledgeMicrosoft WordMicrosoft ExcelRoot Cause AnalysisInvestigationsAseptic manufacturing experience

Required

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

Preferred

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

Knowledge of cGMPs 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