Senior Associate Quality Assurance

Collabera

Thousand Oaks (CA)

Vor Ort

USD 48.216 - 50.971

Vollzeit

14 Tage+

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Benefits dieser Stelle

Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Paid vacation time
Paid parental leave
Paid holidays annually

Zusammenfassung

A leading quality assurance firm in Thousand Oaks, California, is seeking a Senior Associate, Quality Assurance. This role entails providing real-time QA support and oversight in clinical/commercial drug substance production. Ideal candidates should have hands-on QA or manufacturing experience in a GMP environment and strong critical-thinking skills. The position offers a competitive pay rate of $35.00 - $37.00 per hour, alongside comprehensive benefits including medical, dental, 401(k), and paid time off.

Qualifikationen

  • Experience in a GMP environment is preferred.
  • Strong critical-thinking skills.
  • Bachelor's degree may enhance qualifications, but it's not mandatory.

Aufgaben

  • Provide compliance oversight to Manufacturing and Facilities.
  • Conduct electronic batch record reviews.
  • Facilitate SOP revisions and approvals.

Kenntnisse

Critical thinking
Hands-on QA experience
GMP environment knowledge

Ausbildung

Bachelor's degree in Biochemistry, Biology, Chemistry, or related scientific disciplines

Jobbeschreibung

Position Overview

The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real‑time, floor‑based QA support. The position supports Clinical/Commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and facility events. Ideal candidates will have hands‑on QA or manufacturing experience in a GMP environment with strong critical‑thinking skills prioritized over academic credentials. A bachelor's degree in Biochemistry, Biology, Chemistry, or related scientific disciplines is preferred but not required.

Responsibilities

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.

Salary and Other Compensation

The annual [salary/hourly rate] for this position is between $35.00 -$37.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits
  • [medical insurance]
  • [dental insurance]
  • [vision insurance]
  • [401(k) retirement plan]
  • [life insurance]
  • [long‑term disability insurance]
  • [short‑term disability insurance]
  • [paid parking/public transportation]
  • [Paid time off]
  • [Days /hours of paid sick and safe time]
  • [Days/hours of paid vacation time]
  • [Weeks of paid parental leave]
  • [Paid holidays annually]
  • [any additional benefits applicable]
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