Sr. Quality Systems and Compliance Specialist in El Segundo, CA at Apex Life Sciences

Date Posted: 5/30/2018

Job Snapshot

Job Description


A well-regarded company focusing on patient therapies is seeking a Sr. Quality Systems and Compliance Specialist to join their team. This is a great opportunity to work for an industry leader!

Please send resumes to Dave Hurt at dhurt@apexlifesciences.com ASAP for consideration!

RESPONSIBILITIES:

  • Establish and maintain a deviation and Laboratory Investigation management system compliant with regulatory, quality, and company requirements.
  • Provides guidance and advice on methods, procedures, standardization and requirements associated with the deviation and LIR systems
  • Responsible for system triage meeting facilitation.
  • Collaborates with cross-functional departments to ensure timely implementation of quality records.
  • Support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
  • Support deviation system and ensure proper investigation and root cause analysis are performed and corrective actions implemented.
  • Develops, implements and delivers training content for deviation and laboratory investigations processes and procedures.
  • Responsible for procedure reviews and facilitating procedure updates for the deviation and LIR systems.
  • Assure that personnel are adequately trained in the principals, policies, and procedures of the deviation and laboratory investigations systems.
  • Support tracking and communication of site metrics to management.
  • Identify and escalate compliance gaps across quality systems.
  • Perform other duties as required.

REQUIREMENTS:

  • BS/BA with minimum of 5 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.  MS/MA degree with a minimum of 3 years of experience. 
  • Strong knowledge of GMP, SOPs and quality system processes.  
  • Excellent organizational skills and ability to review and update processes or procedures.

#LI-HURT

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.