Role Type: Contract
Work Location: WFH
Work Hours: Fulltime
Keywords is looking for a coordinator to work in deviation management at our Pharmaceutical client's Temperature Excursion Investigation Center (TEIC).
Their responsibilities will include:
- Respond to all Temperature Excursion submissions and communications swiftly, clearly, and accurately. This includes communicating with medical professionals around the world.
- Ensure dispositions (resolutions) are processed in a timely manner, following receipt of an accurate Data Collection Form.
- Collaborate with the Development Stability Group, Clinical Supply Coordinators, Global Distribution, Outsourcing, Packaging, and others to provide Fit for Use disposition, resolve issues, and ensure adequate supply is available at sites to avoid patient impact
- As needed, assist in identifying the root causes of any process related issues, affecting, but not limited to compliance and quality.
- Follow all procedures for determining material disposition and create clear documentation of all decisions to demonstrate a controlled process.
- Document all steps in deviation/change management platform.
Keywords provides a competitive compensation package, good benefits and a casual, fun, productive and supportive working environment. We empower people to perform to the best of their ability with our “can do” attitude. We appreciate and embrace flexibility and learn at every opportunity to grow ourselves through experience, training and tackling new challenges. This is what makes us Keywordians.
- Microsoft Office including Excel
- Strong interpersonal skills
- Strong organizational skills
- Attention to detail
- Project coordination skills
- Pharma experience a plus, though not mandatory
- Knowledge of SAP or TrackWise a plus
At KeyWords we provide all our workforce with:
- Paid Time Off (including sick days and holidays)
- 401k (3% matching)
- Medical, Dental and Vision benefits