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We're looking for a Quality Assurance Associate III
, working in Pharmaceuticals and Medical Products
industry in 153 2nd Avenue, Waltham, Massachusetts, 02451, United States
- Promote quality and compliance of standards at global PV
- Liaison between PV Quality Assurance team and GPV
operations and other organizational teams (for transversal activities)
responsible for contributing to PV activities, deliverables and outputs.
- Track, trend and report PV Quality issues.
- Perform robust RCA of quality issues and oversight of
CAPAs to support GPV process improvements.
- Support GPV to create and maintain robust PV quality
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Strong analytical skill and developed insight for
analysis of issues ensuring scientific rigor/good quality in all analyses and
decision-making based on sound risk-based judgment
- Excellent writing and communication skills
interpersonal skills: interaction with individuals of various background such
as various levels in other departments and other countries
- Ability to provide clear concise summary and identify key
issues which are a concern for GPV
- Ability to work independently and successfully manages
multiple priorities simultaneously
- Ability to identify gap in quality issue and investigate
to clarify root cause
- Demonstrated ability to participate in creation of a
corrective action plan and monitor its effectiveness to meet the needs of
associates/department/unit/country/GPV Computer literacy (Microsoft Office)
- Good understanding of Quality Management System and their
- In-depth knowledge of International Pharmacovigilance
requirements, US FDA, EMEA requirements/international guidelines, ICH/CIOMS
- Bachelors degree in Health Science and certified
health professional degree preferred but not required (Pharmacist or
Pharm Degree or Bachelor of Nursing degree)
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?