Quality Assurance Specialist

2 months ago

Burbank, United States Certified Laboratories Inc Full time
Job DescriptionJob Description

Certified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries. 

We have embarked on an important journey to unify and strengthen our culture by living these core values: Start with the Customer, Drive to Deliver, Commit to Safety and Quality, and Believe in the Team — including believing in you.

ESSENTIAL RESPONSIBILITIES

  • Execute daily QA functions as directed by the QA Supervisor and/or QA Lead.
  • Prepare, track, and review all QA documentation required to maintain the Quality Management System.
  • Complete and respond to all customer-supplied regulatory/audit questionnaires and quality documentation requests.
  • Review certificate of analysis reports from the Document Control department.
  • Conduct customer-requested Out of Specification (OOS) investigations.
  • Prepare and revise Standard Operating Procedures (SOPs) as needed.
  • Oversee equipment maintenance and calibrations when necessary.
  • Perform annual GMP/GLP internal audits and generate Corrective and Preventive Actions (CAPAs) if required.
  • Maintain records.
  • Review testing activities related to OOS investigations.
  • Assist in the laboratory’s inter-laboratory proficiency testing program (A2LA documentation).
  • Conduct routine SOP training and maintain training program documentation.
  • Oversee and train QA personnel.
  • Facilitate internal audits.
  • Work with lab personnel to ensure proper documentation and labeling in the laboratories.
  • Assist with onboarding new employees.
  • Maintain records of test method references in the master list of documents.
  • Assist the QA Supervisor with training personnel on required SOPs, refreshers, and safety trainings.
  • Ensure First Aid kits are fully stocked and compliant with OSHA standards.
  • Maintain all company legal, regulatory, and quality certifications, registrations, and credentials.
  • Manage and respond to customer OOS and Technical Quality Assurance email inquiries.
  • Maintain the organizational chart.
  • Perform other duties as assigned.

MINIMUM QUALIFICATIONS

  • Bachelor degree in a relevant field
  • 3 or more years of Quality Assurance work in the cosmetic, nutritional, pharmaceutical, or FDA regulated industries.
  • Strong technical writing skills.
  • Knowledge of cGMP, FDA regulations, and 21 CFR.
  • Effective communication and collaboration skills with lab personnel.
  • Able to handle multiple tasks and work in a fast paced environment.
  • Able to adapt to changes to improve company process.

PHYSICAL DEMANDS

  • Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components
  • Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens
  • Noise level varies from quiet to loud
  • Temperature varies from hot to cold
  • Interactive and fast-paced team oriented tasks
  • Occasionally lift and/or move up to 25 pounds.
  • Color vision and depth perception

Benefits:

  • Progressive 401k Retirement Savings Plan
  • Employer Paid Short- Term and Long-Term Disability, and Life Insurance
  • Group Medical
  • Tuition Reimbursement
  • Flexible Spending Accounts
  • Dental
  • Paid Holidays and Time Off
  • Many positions which qualify for the company bonus program

Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.



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