Quality Assurance Engineering Manager manages inspections of raw materials, equipment, processes, and finished products. Implements quality standards and protocols for quality assurance testing models. Being a Quality Assurance Engineering Manager assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. Ensures projects are completed on time and within budget. Additionally, Quality Assurance Engineering Manager acts as a technical advisor to quality assurance engineering team regarding projects, tasks, and operations. Requires a bachelor's degree. Typically reports to a head of a unit/department. The Quality Assurance Engineering Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Quality Assurance Engineering Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
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Company: One of Our Clients
Job Description:
Job Title - Quality Assurance Manager - Validation
Location – Groton, CT 06340
Duration – 12 Months (Extendable)
Pay Rate: $30.00 – 37.65/hr on W2
Description:
As a Quality Assurance Manager – Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Pfizer Groton, CT site.
This is an onsite role with a Monday -Friday , 1st Shift schedule.
ROLE 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, Pfizer 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.
BASIC QUALIFICATIONS
• 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.
PREFERRED QUALIFICATIONS
• 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
Awards and Accolades:
Regards,
Kajal Singh
Associate IT Recruiter (Pharma and Life Sciences)
Net2Source Inc.
Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA
Office: (201) 340-8700 x 980 | Cell: (201) 777-4217 | Fax: (201) 221-8131| Email: singh.kajal@net2source.com