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Quality Assurance Specialist Biopharmaceutical 502

Company Name:
MedTeam Staffing
This is a contract job opportunity
Position: Quality Assurance Specialist Biopharmaceutical 502
Location: Cheshire CT
Projected duration: 5 months
Job code: 502
Position Description
Leads daily activities related to the processing of training records associated with the GMP training program by creating courses in the electronic training system.
Develops and oversees implementation of annual site training plan.
Leads daily activities related to processing and maintenance of controlled GMP documents associated with document management functions (procedures, specifications, reports and batch records).
Proposes and participates in continuous improvements to applicable standard operating procedures and electronic systems related to document control, GMP training, and quality systems.
Owns and reviews minor global and local change controls, works cross-functionally to ensure effective implementation against regulatory approval requirements and project timelines.
Reviews and assesses deviations; participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
Review and approves Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
Trends and analyzes quality system data to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes appropriate CAPA.
Creates and reviews documents including Standard Operating Procedures.
Provides support for internal audits for GMP compliance.
Requirements
Minimum of 5 years GMP related experience in biopharmaceutical / pharmaceutical or related industry.
Experience with GMP global regulatory requirements.
Experience with electronic systems, e.g. FirstDocs, SAP, and TrackWise
Education:
BS/BA degree in Chemistry, Biology or related field

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