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Quality Assurance Specialist


Posted Friday, July 14, 2023

Posting ID: JP-003907039

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Camarillo, CA
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Manufacturing company that services the biotech and medical device industries is looking for a QA Specialist to join their team! Opportunity to expand your skills within technical writing, investigations, internal and external audits, and root cause analysis.


  • Excellent written and verbal communication
  • Knowledge of QA within GMP or ISO 9001
  • Experience running internal and external audits


  • Opportunity for a hybrid schedule at 3 months
  • Growing company in the process of acquiring multiple manufacturing sites
  • Expanding Camarillo lab in 2024


Collaborate with stakeholders to the management of the Quality System. Recommend and implements changes to the existing quality system with regards to nonconforming product, corrective/preventive actions, document control, quality control inspections and product release, internal audits, validations and equipment calibration and maintenance programs.

Primary Responsibilities:

  • Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements.
  • Regulatory submissions and compliance with applicable national and international regulations.
  • Conducts audits and reviews/analyzes data and documentation. Manage internal audit program and support QMS related activities.
  • Host customer audits.
  • Perform supplier audits, support supplier audit program.
  • Initiate, investigate and complete corrective actions (CA). Participate in the MRB meetings. Includes ability to apply problem solving tools and methods to coordinate and/or lead investigation teams.
  • Participate in the management and execution of equipment, process and software validation.
  • Manage the equipment calibration and maintenance program.
  • Provide directions for all aspects of testing related to manufacturing.
    • First article inspections
    • In-process release inspection.
    • Final QC release of finished goods.
    • Document review.
  • Ensures that all inspections and procedures are properly completed and documented.
  • Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
  • Perform environmental monitoring of cleanrooms and bioburden results. Provides solution for microbial failures.
  • Assists department with continuous improvements initiatives or lean projects.
  • Can serve as Quality Assurance representative on facility projects.
  • Lead/support investigations and response for customer complaints.


quality assurance, internal audits, external audits, GMP, document control, ISO 9001, drug manufacturing, regulatory audit, regulatory, change controls, deviation management, EQMS

Experience Level:

Intermediate Level

Contact Information

Recruiter: Aileen Garland

Phone: (310) 800-9092


The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Tag icon for HybridHybrid
batch records
document control
attention to detail