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Specialist, QA Operations

Location
Arcadia, California
Posted
1 Sep 2022

About:

My client is a privately-owned CDMO focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. They are a small, biotech startup headquartered in Arcadia, CA. Their innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes.


Reports to: Director, Quality Site Head

Travel: Occasional. Less than 10%


Position Summary:

This position will be responsible for supporting the Quality Operations in the production environment. This person will review and approve deviations, protocols, change controls, risk assessments, and CAPAs. There are no supervisory responsibilities included in this role however, the candidate must be able to deal with people across all levels of the organization. This person will have the opportunity to partner with TechOps functions to ensure the successful complaint, efficient, and effective quality operations.


Primary Responsibilities:

  • Serves as an SME for Quality operations to support production operations
  • Lead and/or support Deviation investigations, CAPAs, Change Controls, Risk Assessments to support company production
  • Support internal audits and compliance activities
  • Lead and support continuous improvement activities
  • Act as a change agent to improve production operations


Skills:

  • Knowledge of cGMP, GXP, GAMP, 21CFR part 11, GDP
  • Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment
  • Ability to motivate and inspire others to excellence
  • Strong written and verbal communication skills
  • Excellent interpersonal skills with experience dealing with a diverse workforce


Education:

  • Bachelor's degree in Science related field, preferably Life Sciences or Engineering.
  • Minimum of 5 years of work experience in the Pharmaceutical, Life Sciences industry with CGMP

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Details

  • Job Reference: 701064301-2
  • Date Posted: 1 September 2022
  • Recruiter: Meet
  • Location: Arcadia, California
  • Salary: On Application