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Senior Quality Assurance Manager
Posted on Oodle - Over 4 weeks ago
- Company:
- Premier Staffing Group
- Location:
- Burlington, MA
Features & Description
JOB SUMMARY: The Senior Quality Manager is responsible for the Quality Assurance (QA) activities involving QA Document Control, Training, Executed Batch Records, Reviewing Incoming Materials Inspection, Investigations, and Corrective and Preventive Actions. The Senior QA Manager interacts with clients for quality related issues. The Senior Quality Manager is involved in regulatory inspections.JOB RESPONSIBILITIES:
1. Scheduling, oversight and performance of all Quality Assurance (QA) activities at the hiring company through their staff.
2. Responsible for the development of staff and systems to ensure compliance with all quality and regulatory requirements.
3. Implements quality goals and objectives
MINIMUM REQUIREMENTS FOR EDUCATION, TRAINING AND EXPERIENCE :
1. Must be skilled in the use of computers, software and spreadsheets.
2. Must have strong organizational skills and ability to prioritize, schedule and multi-task.
3. Must have a minimum of 10 years supervisory/management and/or project management experience in a pharmaceutical company.
4. Bachelor’s degree in science or management.
5. Minimum of 15 years industry experience in a pharmaceutical or biologics cGMP environment. Device experience is a plus.
6. Knowledgeable in FDA cGMPs (21 CFR, 211, 820, and /or other 600); ISO 9001 and 13485 a plus.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES: Responsible for the management staff members in QA.
(To apply, please forward your resume to contact@premierstaffinggroup.com)
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