Overview
Senior QA Validation Specialist Jobs in Spokane, Washington, USA at Scientific Search
Position: (Senior) QA Validation Specialist
(Senior) QA Validation Specialist
(Onsite in NE Washington State, relocation assistance provided)
Company Profile: Our client is a global CMO that provides manufacturing services to Pharmaceutical and Biotech companies in North America, Asia, and Europe.
What You Can Expect To Be Doing:
Provide technical expertise via review and approval of documents including but not limited to Protocols, Acceptance Reports, SOPs, and Specifications.
Provide project and client support as a quality representative.
Work with the production, engineering, maintenance, IT, and technical services departments to assure that all required prerequisite documentation is appropriately developed to support process, cleaning, facilities, aseptic, and filling/packaging activities.
Track and provide technical direction for new and continued validation of processes and equipment to ensure compliance with internal policies and procedures, current industry standards, cGMPs, and current regulatory requirements.
Review product transfer protocols and reports, assess impact to product quality and determine appropriate actions.
Create, and write required SOPs pertaining to documentation and QA Validation.
Review and approve validation protocols, acceptance reports, SOPs, and specifications.
Recognize compliance issues that may occur and provide QA SME support for change control and system improvement.
What You Will Bring To The Table:
Bachelor of Science Degree in a scientific discipline or 5 years of experience in lieu of degree required for a Specialist. Bachelor of Science degree or 10 years’ experience in lieu of a degree required for a Sr. Specialist.
Must have 5 years of related experience for a Sr. Specialist.
Minimum of 2 years’ qualification/validation experience.
Must have 3 years’ pharmaceutical experience.
FDA Regulated Industry required.
Proficiency in Microsoft Word, Excel, and PowerPoint required.
This position requires an in-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with the manufacture of sterile products, testing required on those products, and relationship of quality principles with manufacturing and testing.
Seniority Level: Mid-Senior level
Employment Type: Full-time
Job Function:Quality Assurance
Industries: Pharmaceutical Manufacturing
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Title: Senior QA Validation Specialist
Company: Scientific Search
Location: Spokane, Washington, USA
Category: Quality Assurance – QA/QC (Quality Engineering, QA Specialist / Manager), Pharmaceutical (Quality Engineering)
