QC Compliance Analyst in City of Industry, CA at Apex Life Sciences

Date Posted: 8/7/2018

Job Snapshot

Job Description


Primary Duties and Responsibilities

  • In-depth understanding and adherence to the Quality System requirements established by laboratory. 
  • Responsible for ensuring QC compliance with all Federal, State, local and Company regulations, policies, procedures and company guidelines related to Health, Safety and Environmental practices
  • Develop, maintain and report QC metrics and statistical analysis of QC data.  Inform and work with Senior Management to address adverse trends.
  • Identify gaps in corporate practices, policies and procedures and facilitate the Company’s prioritization of work based on current regulatory environment, guides and regulations
  • Develop and implement systems to ensure inspection readiness
  • Work closely with and support OOS, NCs, LIRs, SOPs, CPAs, ORs and CAPAs for all testing that occurs within the contract laboratory for GMP production
  • Provide SME (Subject Matter Expertise) for the evaluation and conclusion of laboratory investigations
  • Provide the support required to generate installation/operation/performance qualifications for QC analytical instrumentation
  • Ensure QC instruments and equipment are calibrated and maintained
  • Understand and follow Quality System Documents relevant to responsibilities, testing, e.g. SOPs
  • Support for the training program as it pertains to the QC department
  • Support the development and execution of validation studies and research projects
  • Support/Lead various QC projects

Job Requirements and Qualifications

  • Experience working in a laboratory that performs testing within a regulated environment
  • Excellent documentation and investigation skills required
  • Working knowledge of laboratory equipment troubleshooting, qualification, maintenance and calibration, required
  • Statistical data analysis experience, preferred
  • Knowledge of food chemistry/microbiology, specifically milk testing, or infant formula testing preferred
  • Excellent interpersonal, communication, presentation, and organizational skills
  • Must be capable of working in a FDA regulated environment

Qualifications

  • BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering; Chemistry or other applicable related fields
  • Minimum of 4 years’ experience with BS (2 years with advanced degree)  in Pharmaceutical, Biological or Biotech industry; hands-on experience in manufacturing operations or pilot lab / scale-up operations; experience in pharmaceutical scale-up activities, pharmaceutical validations, or extensive laboratory experience in protein chemistry highly desired.

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.