Quality Validation Specialist
Groton, CT
Experience: 0
Category: Scientific & Clinical
Brand: Joulé
Job ID: 321140
Date Posted: 06/06/2024
Shortcut: http://jobs.systemone.com/hMAljU
Job Title: Quality Validation Specialist
Location: Groton, CT
Hours/ Schedule: Monday -Friday, 1st Shift schedule.
Type: Contract
Responsibilities
- Provide validation and qualification guidance to customers for equipment and computerized systems related to solid dosage manufacturing, API manufacturing, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.).
- Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures and periodic reviews. Quality lead on large projects and contributes to validation strategy.
- Participate and/or lead quality investigations including root cause analysis, Human Performance assessments, and approval of investigation reports.
- Review and approve change controls, quality investigations, and corrective/preventive actions.
- Participate in the development of procedures which increase efficiency while maintaining high quality standards
- Provide support to internal audits (e.g. MSQA) & regulatory inspections (e.g. FDA, MHRA) as needed.
- Participate on special projects, teams and global initiatives.
Requirements
- Bachelor’s Degree (B.S.) with 3-5 years technical/scientific/pharmaceutical experience/Engineering or equivalent.
- Must have 3-5 years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.
- Extensive knowledge of cGMP’s related to equipment and computer system validation/qualification.
- Expertise in quality investigation techniques
- Experience with Quality Risk Management (QRM)
- Previous quality assurance experience
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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