MCS Senior Associate Quality Assurance

• FULLY ONSITE AT USTO
• DAY & SWING SHIFT
• This position supports 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 and CAPA records.
• 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.

• 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.
• Solid understanding and application of aseptic behaviors and principles

• 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.

• Experience working with Quality Systems / QA
• Ability to perform GMP operations
• BATCH RECORD EXPERIENCE (MANUFACTURING BACKGROUND EXPERIENCE)
• Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field (strongly preferred)

• Duties include electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and qual‐ ity approval of non-conformances and CAPAs.
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
• The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

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