Quality Control Analyst in Los Angeles, CA at Apex Life Sciences

Date Posted: 5/10/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Microbiology Quality Control Analyst to join an established team in the Los Angeles area!

Description:

  • Conduct biological, microbiological and physical analyses on raw materials, stability, in-process samples and final products, and samples collected from systems monitoring programs, following controlled test procedures.
  • Work under some Supervision. 

Responsibilities:

  • Use sophisticated laboratory instrumentation and computer systems to collect and record data.
  • Perform sampling for viable/non-viable 'surface monitoring'
  • document their tasks, as well as performing plate readings of the samples
  • May perform advanced assays requiring precise analytical skills and understanding of biological and chemical principles. 
  • Perform review of test data with application of GDP. 
  • Complete all testing, including special project / protocol testing in a timely manner.
  • Prepare and/or direct lab protocol studies under some supervision.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Ensure data integrity and regulatory compliance is maintained in assigned area and/or system. 
  • Demonstrate familiarity with product specifications, process reference files, code of federal regulations, and compendia requirements. 
  • Use Global LIMS or other computerized systems for entering and approving test results. 
  • Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. 
  • Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines.
  • Will be expected to do laboratory walk through to ensure area is suitable for hand off to oncoming shifts. 
  • Prepare and update SOPs as required under supervision 
  • Perform equipment maintenance and calibrations as required.
  • May be the subject matter expert on assigned equipment. 
  • Drive Lean principles such as 5S throughout daily work activities. 
  • Ensure personal training requirements are met and that training records are current. 
  • May be required to perform microbial and particulate monitoring of clean rooms throughout the Manufacturing Facility for qualification purposes. 
  • May perform removal of hazardous waste. 
  • Other duties as assigned by departmental management. 

Requirements:

  • Bachelor's degree in Microbiology or biological science with  Laboratory coursework with 0-2 years of relevant experience. 
  • Requires testing and work in a 'hood'
  • Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • Knowledge of GMPs (good manufacturing practices)
  • Ability to manage multiple tasks concurrently and drive tasks to completion in a timely manner. 
  • Computer literate and competent with a solid knowledge of word processing and spreadsheets (such as Microsoft Office). 
  • Must be detail-oriented, conscientious, and responsible. 
  • Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned. 
  • Effective interpersonal communication and influencing skills
  • Must have effective verbal and written communication skills. 
  • Must have basic understanding of laboratory instrumentation and chemical handling. 
  • Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs and USP, JP, EP procedures. 
  • Must be able to learn new computer systems and programs in a timely manner. 
  • Must be able to lift, push, pull and carry up to 25 lbs. 
  • 20/20 near vision required (corrected as acceptable).
  • Must be able to recognize and distinguish among the colors red, yellow, and blue. 
  • Must be able to work in controlled environments requiring special gowning.
  • This may include additional hearing protection for loud areas. 



#LI-BW1

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.