QC Analytical Scientist - GMP, method validation in Andover, MA at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a Quality Control Analytical Scientist to support analytical testing activities for a top Pharamcetuical company in Andover, MA.

Responsibilities:

  • Perform various HPLC, UV spectrophotometry, and ELISA methods. The candidate will also be responsible for supporting technical writing, investigations, and other QC analytical business activities at the site.
  • Perform work in a cGMP Quality Control Analytical lab. 
  • Prepare and record buffers and reagents, etc., and maintain work area in a neat and orderly manner.
  • Perform and review analytical testing of in-process, drug substance, and drug product samples.
  • Identify basic technical issues, atypical or out-of-specifications test results, instrument
  • malfunctions and methodology problems and participates in the investigation to resolve and correct.
  • Maintain all related data and records in compliance with cGMPs and quality procedures.
  • Support laboratory investigations
  • Perform laboratory support functions including method revisions and maintain work area in compliance with cGMP and quality procedures.
  • Participates in continuous improvement culture within labs. Utilizes continuous improvement tools such as DMAIC.
  • Interact with immediate group and across the Quality organization.

SKILLS

  • B.S. in Biology, Chemistry or related scientific discipline with a minimum of 5 years of related laboratory experience
  • Lab Experience in basic analytical methods: HPLC, UV, pH 
  • Knowledge of Advanced analytical methods: Peptide map and Oligosaccharide, ELISA, iCE, Bioassay, CE 
  • Strong oral and written communication skills 
  • Knowledge and understanding of cGMP and industry standards
  • Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
  • Experience working in cGMP, regulatory environment.

***For immediate consideration, please email your updated resume to Lillie at Ljohnson@apexlifesciences.com with 'QC Analytical Scientist' in the subject line.

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 844-463-6178.




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