Randstad Life Sciences US | Sr. Associate, Quality Assurance

1 week ago

thousand oaks, United States Randstad Life Sciences US Full time

Immediate opportunity for a Senior Quality Assurance (QA) Associate to support the Quality Assurance program under the Plant QA organization, providing daily oversight of the Drug Substance manufacturing areas.


Position Type: 3 year contract (through January 2028)

Schedule/Shift: 40 hrs./week, 8 hrs./day; will rotate shifts based on the business supported. Rotation every 6 mos. across day (7am-8pm), swing (1pm-12am) and night (7pm-8am) shifts. Must be flexible to work any shift.


Position Overview: Under general supervision, MCS Senior Associate Quality Assurance provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems.


Essential Duties and Responsibilities:

  • 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.
  • 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.
  • Other duties as assigned.


Qualifications:

  • 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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