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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
true
MCS Manufacturing Senior Associate
Posted: 09/06/2024
2024-09-06
2024-10-12
Employment Type:
Contract
Job Category: Manufacturing
Job Number: 3973
Job Description
The Sr. Associate, Manufacturing will successfully inform, influence, and assign accountability to members of cross-functional teams that include Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Responsibilities include, but not be limited to; New Product Introductions (NPI) program management and non-capital project management. The individual will be responsible for leading projects of diverse subjects and complexity and have proven strong communication and collaborative capabilities, both within and outside of the immediate team.
Responsibilities:
Responsibilities include, but not be limited to; New Product Introductions (NPI) program management and non-capital project management. The individual will be responsible for leading projects of diverse subjects and complexity and have proven strong communication and collaborative capabilities, both within and outside of the immediate team.
Responsibilities:
- Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right the First-Time approach.
- Strong project management skills, with prior project experience preferred.
- Timely closure of change control records in relation to procedural guidance and/or disposition timelines
- Represent Building 20 Manufacturing as the receiving site for incoming Technology Transfers/New Product Introductions into Building 20
- Identifying improvement opportunities within the organization and take proactive steps to build consensus to implement those opportunities
- Succinctly communicate verbally and in writing to staff and leadership
- Presenting records and business processes to a variety of audiences, including auditors and inspectors
- Participating/leading Continuous Improvement Transformation activities
- Champion safety and compliance at all times
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- Degree in life sciences or engineering
- Experience with PAS X Werum software for electronic batch records
- Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection
- Experience leading change controls in TrackWise
- Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory
- Demonstrated technical writing skill
- Demonstrated ability to work in a team
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