: Specialist Product Quality (JP7959)
West Greenwich Rhode Island 02817
: 6 months (no extensions)
Job posting date
: 24 November 2020
working on site 75% of the time, 8-5 standard hours, and potential evenings as the process requires
3 Key Consulting is hiring a Specialist Product Quality for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Top Must have Skill Sets:
- Manage the development and implementation of clinical and commercial product specifications, in process control documents, and other specification related documents.
- Facilitation of specification development meetings and the generation of detailed and communicate meeting minutes/action items to all attendees.
- Other tasks include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.
- Own nonconformance records (NC), and lead or coordinate activities required to advance NCs to closure. Implement and maintain a product quality data tracking system that facilitates meaningful analysis of release and in process test results (data mining).
- Additional responsibilities include assisting Product Quality leader function by facilitating team meetings and drafting/distributing meeting minutes, assisting in the management of product sample plans, as well as other assignments and projects as assigned.
- Skills: degree in life science, business or engineering; project management and/or industry experience; experience using computer software such as MS Office (i.e. Excel, Word, Project).
- Education: Bachelor's Degree in Engineering or Scientific Field
- GMP experience
- Single use technology experience
- Cell Culture Experience
- Purification experience
- Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
- Strong project management skills with ability to multi-task and function in a dynamic environment
- Excellent communication skills, drive, and sense of urgency
- Demonstrated ability to forge and maintain strong relationships within other functional areas
- Ability to recommend, judge, and make good decisions in complex situations
- Ability to tactfully and effectively negotiate and influence.
Employee Value Proposition:
- Supporting Manufacturing
- SOP, Deviation,
- Documentation ownership,
- trouble shooting of manufacturing processes,
- root cause analysis
working on a new product introduction
No experience with GMP or Manufacturing
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.