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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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MCS Senior Associate Quality Assurance
Posted: 01/22/2025
2025-01-22
2025-02-24
Employment Type:
Contract
Job Category: Quality
Job Number: 4193
Job Description
This position supports the Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas.
Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems.
Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations .
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
Basic Qualifications
Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems.
Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations .
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
Basic Qualifications
- 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
- Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
- Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.
- Also, ability to make Quality based decisions in order to ensure compliance.
- Experience managing projects through to completion & meeting timelines.
- Evaluating documentation and operations according to company procedures.
- Experience working with Quality Systems, Strong organizational skills and ability to manage multiple tasks at one time/ Effective communication skills (both written and verbal)
- Demonstrated ability to work as both a team player and independently
- Display leadership attributes and drive improvement initiatives.
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