**Hybrid Role in New Haven. CT**
Job opportunity with a top biopharmaceutical company that is looking for a Quality Assurance Mgmt. III to join their team on a 12-month contract with an opportunity for conversion or extension!
Qualifications:
- 10 years' + experience in Quality Assurance within the pharmaceutical industry.
- 3+ years' experience with Good Distribution Practices Compliant Commercial Operations, Supply Chain and/or Product Distribution activities within the pharmaceutical industry.
- Bachelor's degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology).
Job Description/Skills:
- Use deep process knowledge and experience to assist global business partners with the creation, review, approval, closure, and monitoring of internal and external QMS records (for example, deviations, CAPAs, change controls, and laboratory investigations).
- Provide tactical and operational support to the Global Quality Systems Business Process Owner, including but not limited to, stakeholder management, process improvement execution, communication, technical writing, and learning program development.
- Sustain and improve QMS compliance through the implementation of value-added Quality Management System (QMS) improvements in collaboration with global stakeholders to achieve Alexion's strategic Quality priorities.
- Develop and deliver quality systems training.
- Create and update procedural documentation and work instructions with accuracy and clarity.
- Support implementation of quality improvement initiatives and integration activities.
- Identify, assess, communicate, manage, and mitigate quality system risks.
- Evaluate new or revised regulations for compliance gaps and support remediation efforts for gap closure.
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
