MCS Senior Associate Quality Assurance

2 weeks ago

Thousand Oaks, United States Aditi Consulting Full time
Summary:
This position supports Client's 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:
  • 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 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

Top 3 Must Have Skill Sets:
  • Experience working with Quality Systems / QA
  • BATCH RECORD EXPERIENCE
  • Plant Quality Assurance providing quality oversight to manufacturing

Preferred 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.


Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

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