Hikma Pharmaceuticals USA Inc.

Quality Lab Associate III, Chemistry

Job Location US-NJ-Cherry Hill
Posted Date 5 months ago(3/10/2021 12:25 PM)
Job ID
2021-6907
Job Function
Quality
Shift
Cherry Hill First Shift

Overview

Conduct chemical, biochemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming components and raw materials to finished goods and stability. Perform laboratory investigations for OOS results or other exceptions. Proficiently uses analytical instrumentation and troubleshoots equipment issues. Execute validation for laboratory instruments and methods and conducts routine/non-routine testing. Write/ revise standard operating procedures, protocols, test methods and change controls as needed. Works independently.

Responsibilities

  1. Conduct critical chemical, biochemical and physical analyses on incoming components, raw materials, initial, in-process, final products and stability, and samples collected from water for injection systems at Hikma manufacturing facilities, along with customer compliant, foreign vials and retain samples.
  2. Work on special projects / protocol testing that involves new methods and instrumentation.
  3. Assist supervision with laboratory investigations for OOS results or other exceptions.
  4. Write and execute validations for laboratory instruments and methods.
  5. May serve as mentor to other Quality Laboratory positions. Provide training and work direction for Quality Laboratory Associate I and II positions as required. Manage work flow and laboratory release functions in specified laboratory areas and on off shifts.
  6. Perform review of test data, which includes overall cGMP documentation practices and release functions in LIMS or other computerized systems.
  7. Use sophisticated laboratory instrumentation (HPLC, GC, FTIR, AA, UV/Vis, ICP-MS, etc.) and computer systems to collect and record data.
  8. Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
  9. Complete all testing, including special project / protocol testing in a timely and appropriate manner.
  10. Execute validation studies in support of manufacturing processes and R&D projects including but not limited to cleaning validation, process validation, light filter tubing studies and method transfer/validations.
  11. Conduct reference standard qualifications
  12. Maintain data integrity and ensure compliance with company SOPs and specifications, USP, Ph.Eur., FDA, GLP, GDP and cGMP regulations.
  13. Investigate deviations and write exception documents.
  14. Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality and provide new product support.
  15. Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs and Job Aids.
  16. Perform equipment maintenance and calibrations as required, troubleshoot and resolve instrumentation issues and participate in new instrument qualifications.

Qualifications

Bachelors Degree in Chemistry or related science with minimum of 5 years' experience in Pharmaceutical industry, or Masters Degree in Chemistry science with 1-4 years' experience.

 

  1. Proficient in wet and instrumental methods of analyses
  2. Advanced laboratory skills, basic knowledge of statistical method.
  3. Strong technical problem solving skills
  4. Ability to handle multiple tasks concurrently, and in a timely fashion
  5. Computer literate.
  6. Must be able to communicate effectively with supervisors and peers.
  7. Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.
  8. Must be able to accommodate a flexible work schedule (weekends, shift, etc.) which may be required for business needs.

 

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Notification to Agencies

Please note that Express does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, Express will not consider or approve payment to any third-parties for hires made.

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