QC Associate, Analtyical in El Segundo, CA at Apex Life Sciences

Date Posted: 7/18/2018

Job Snapshot

Job Description



Apex Life Sciences is searching for a QC Associate for our growing client in the Los Angeles area. This is a great opportunity to work with an industry leader!

Responsibilities (include but are not limited to):

  • Perform testing of raw materials, intermediates and final products by following analytical methods.
  • Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
  • Track and test products according to Stability protocols.
  • Work with internal and external resources to maintain lab in an optimal state.
  • Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
  • Assist in the preparation of dossiers and data packages for interactions between company and Regulatory agencies.  Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.  Provide updates at daily and weekly meetings.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Perform other duties as required.

Requirements:

  • Strong knowledge of GMP, SOPs and quality control processes.  
  • Identifying, writing, evaluating, and closing OOS’s and investigations.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Required:  Bachelor or Master’s degree in biotechnology or related field with 4 – 5 years of Quality Control experience or PhD molecular biologist or biochemist preferred with 1-2 years of Quality Control experience.
  • The ideal candidate is well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211). 
  • Preferred:  Experience in the biotech and/or pharmaceutical industry. 
  • Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule, such as swing shift hours.

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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.