Quality Control Analyst in Exton, PA at APEX Systems

Date Posted: 2/14/2020

Job Snapshot

Job Description

Job #:  1047696

Apex Systems is seeking a Quality Control Analyst for one of our growing Biotech clients located in the Malvern, PA area.
  • Execute Analytical Test Methods for bulk intermediate testing and final product release testing
  • Execute testing for raw materials
  • Author and revise QC SOPs and ATMs as necessary to maintain compliance
  • Review of Quality Control raw data for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product 
  • Timely response to Out Of Specification (OOS) results, including notification to area supervision
  • Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule
  • Maintain housekeeping in the laboratories
  • Assist the Quality Control Supervisor in daily operations, as needed
  • Perform Growth Promotion testing on prepared media
  • Direct Sterile Media Fill Trials and perform support testing
  • Authoring and/or executing protocols and generating technical reports
  • Analytical method validation
  • Equipment qualification
  • Training of other employees
  • Completion of thorough Laboratory Investigation Reports (LIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented

Computer Skills:     
  • To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.

  • Minimum Bachelor of Science degree in a scientific discipline

  • 3-5 years Quality Control experience in a similar role in the biologics or pharmaceutical industry
  • 2-3 years experience in mammalian cell culture in an academic or industrial laboratory
  • Knowledge of basic laboratory skills (aseptic technique, etc.) are required
  • Knowledge of Current Good Manufacturing Practice and Industry standards
  • Familiarity with analytical equipment including UV absorbance plate readers, Flow cytometers, microscopes and pH meters
  • Experience in aseptic processing and mammalian cell culture production
  • Excellent verbal and written skills
  • Good interpersonal communication skills
  • Must be open to occasional off shift and weekend work

For immediate consideration, please email a copy of your resume to jkuchenbrod@apexsystems.com
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 844-463-6178.