Quality Validation Specialist

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.