03 Jul
Senior Quality Assurance Specialist
Vacancy expired!
- Woburn MA (100% onsite)
- Rates Depending on experience
Contract to Direct Hire
- Actively contribute to all Quality Systems such as Deviations, Change Control, Out-of-Specifications, CAPA, Training, and Risk Assessments
- Collaborate with other departments to fully support Equipment Qualification and Calibration programs
- Involvement with controlled document systems, including authoring and revising SOPs
- Lead or assist in auditing and investigation activities, perform root-cause analyses, and help to develop corrective and preventative action plans
- Preparation of trend reports across Quality Systems, as needed
- Provide support during Regulatory inspections and client audits
- Assist in maintaining the facility in an inspection-ready state
Lead or assist with continuous improvement initiatives across all GMP functions
- A Bachelor's degree in Science, preferably in biology or similar field
- At least two years of working within the pharmaceutical or biotechnology industry, in a GMP environment
- GLP experience preferable
- Strong understanding of GMPs
Quality Systems experience in GMP environment
An ability to organize, understand, and present complex scientific and technical information at a level that is appropriate for technical and non-technical backgrounds
Attention to detail and analytical thinking
Excellent communication and interpersonal skills
Excellent organizational skills
Experience in Regulatory Inspection participation a plus
Vacancy expired!