Sr. Scientist, QC Systems (Validation) - AZ in Phoenix, AZ at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

Job Description


Sr. Scientist, QC Systems (Validation) 


CORE JOB FUNCTIONS: 

  • Perform validation/qualification on laboratory equipment and utilities, including but not limited to HPLC, GC, FTIR, PSA, and ICP under GMP guidelines. 
  • Write and review IQ, OQ, PQ and validation protocols including summary reports for new and 
  • existing laboratory equipment. 
  • Write, update, review, and approve SOPs for new and existing 
  • laboratory instrumentation. 
  • Perform technical review of documents to ensure compliance with applicable regulations. 
  • Repair and maintain laboratory equipment in a validated state. 

KNOWLEDGE, SKILLS & ABILITIES (KSA's): 

  • Bachelor’s degree required, preferable in Science. 
  • 5 years relevant work experience required, preferably in a regulated environment. 
  • An equivalent combination of education and experience may substitute. 
  • REQUIRES Knowledge of USP, EP, JP and cGMP guidelines. 
  • Advanced knowledge, operational skill, and troubleshooting of pharmaceutical laboratory equipment (e.g., HPLC, GC, PSA, FTIR, TOC, ICP). 
  • Advanced understanding of an instrument calibration program in a regulated environment. 
  • Ability to write and execute instrument qualifications/validations and maintain appropriate documentation. 
  • Advanced skills in managing complex projects. 
  • Advanced ability to interact with internal resources, contractors and vendors to justify new laboratory equipment. 
  • Intermediate knowledge of budgeting, sourcing and acquiring new capital equipment. 
  • Ability to interact with regulatory auditors as Subject Matter Expert (SME) for laboratory equipment. 
  • Advanced ability to train and coach others in laboratory maintenance. 
  • Ability to communicate effectively with peers, department management, cross-functional peers and global teams. 
  • Advanced knowledge of cGMP, JP, USP and EP. 
  • Advanced strategic thinking and ability to work independently.

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.