01 Aug
Contract - Quality Assurance Specialist
Vacancy expired!
- Primarily responsible with supporting quality oversight to VMC operations in the following key areas/activities; engineering, validation/qualification, facilities and utilities support
- Compliance Oversight of Internal Operations - QA Engineering
- Review and approval of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
- Review and approval of change controls, qualification activities, and periodic assessments.
- Review and approval of trending programs (equipment, facility, utilities, etc.)
- Provide support of facilities and engineering projects, including capital projects, annual plant shutdown, and various improvement projects as assigned.
- Compliance Oversight of Quality Systems
- Provide QA support of Equipment and Facility change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Support collaboration with customers to ensure quality systems are monitored and established metrics are met.
- Support monitoring and tracking performance metrics, trends; including site metrics for investigation/CAPA, Equipment and Facility Change Controls, etc.
- Ability to identify risks and communicating gaps for GMP process/systems.
- Support inspection readiness activities and provide support during regulatory site inspections. Provide post inspection support to address any regulatory observations.
- Responsible for timely completion of trainings (100%), goal development, self-evaluation and IDP
Support EM and UM programs and control programs (Veriteq, pest control)
May assist the QA Operations group activities such as area or line clearance.
Support biennial review and approval of department and cross-departmental processes for continuous improvement.
Support compliance walkthroughs of the site and help drive the closure of any observations.
- S in scientific or allied health field (or equivalent degree) and 3+years of relevant work experience
- Knowledge in the following areas:
Knowledge of ASTM E2500, CSV/GAMP, and other associated standards
Vacancy expired!