Quality Assurance Manager - Healthcare jobs in Connecticut

Job Title: Quality Assurance Manager – Validation

Location: Groton, CT

Duration: 12 Months

This is an onsite role with a Monday -Friday, 1st Shift schedule.

Job Description:

• Play an integral part in the QA oversight of Validation and Qualification activities conducted within the Client Groton, CT site.
• 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 leads to large projects and contributes to validation strategy.
• Participate and/or lead quality investigations including root cause analysis, Client 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 for internal audits (e.g. MSQA) & regulatory inspections (e.g. FDA, MHRA) as needed.
• Participate in 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