Senior QA Compliance Specialist

  • location: Irvine, CA
  • type: Permanent
  • salary: $55,000 - $74,000 per year
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job description

Senior QA Compliance Specialist

job summary:
Exciting opportunity to join a growing team at a cutting-edge pharmaceutical company in Irvine. This company provides amazing career growth and the chance to work with a stellar QA team.

 
location: Irvine, California
job type: Permanent
salary: $55,000 - 74,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Evaluate and present information concerning factors such as production capabilities, manufacturing problems, and design and development of new products for consideration by other members of management team.
  • Cooperate with management personnel in formulating and establishing company policies, operating procedures, and goals to comply with regulatory agency standards.
  • Cooperate with management to ensure all quality systems are in place and robust.
  • Assist with preparing the site for inspection. Provide support and expertise during regulatory audits and inspection. Assist with developing strategies to ensure successful audit and inspection outcomes for Quality systems.
  • Author, review and approve protocols, reports and SOPs.
  • Perform problem analysis and corrective action/preventative action (CAPA) management.
  • Provides hands on support throughout the organization to assures Quality Systems activities are actively monitored, actions completed, and periodically re-evaluated.
  • Identify problems and lead projects to improve processes, procedures, and/or practices.
  • Monitor trends/KPIs related to assigned Quality Systems and escalate issues to management
  • Ensure all deadlines are met for action items.
  • Investigate OOS, deviations and complaints provide recommendations and corrective actions and effectiveness plans.
 
qualifications:
  • Bachelor's Degree, preferably in Science, Engineering, Math/statistics, or equivalent combination of education and experience.
  • 6+ years experience in a quality control or quality assurance function associated with manufacturing or equivalent combination of education and experience.
  • 6+ years of experience in GLP or GMP environment is preferred.
  • 1+ years of investigation experience (OOS, Deviation, Complaints) is preferred.
  • Familiarity with 21 CFR 210/211/11 preferred.
  • Able to interpret GMPs and other government regulations.
 
skills: GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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