Quality Assurance Associate III
2 months ago
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The Opportunity
Description
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.
Responsibilities:
- Support quality oversight across GPV GBUs on PV processes, activities, deliverables and/or outputs.
- Promote quality and compliance of standards at global PV level.
- Liaison between PV Quality Assurance team and GPV operations and other company 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.
Our Client
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
Qualifications:
- Bachelors degree, Health Science degree and certified health professional degree preferred but not required (Example Pharmacist or Pharm D or Bachelor of nursing degree)
- 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
- Strong 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 implementation
- In-depth knowledge of International Pharmacovigilance requirements, US FDA, EMEA requirements/international guidelines, ICH/CIOMS
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?
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