Careers at APC

American Peptide Company is an equal opportunity employer and offers a complete benefits package. The following positions are currently available. Please fax or email your resume with job code #.

 
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Posted Date Job code # Position Location
May-15-2013 2013QC42 Senior Validation Chemist Vista


 

Job site/Interview
cGMP Manufacturing: 1271 Avenida Chelsea, Vista, CA 92081  (north San Diego)

2013QC42 >> Senior Validation Chemist

The primary responsibility of the Senior Validation Chemist is method development and method validation.

Specific Duties and Responsibilities:

  • Develop, qualify and validate analytical test methods for drug substances.
  • Troubleshoot old methods, as applicable.
  • Train QC personnel on new analytical methods.
  • Write technical reports, analytical method validation protocols and reports.
  • Write and maintain applicable SOPs.
  • Provide analytical support to Quality Control, Purification and Synthesis, as applicable.
  • Maintain up-to-date knowledge on applicable developments in chromatography.
  • Maintain up-to-date training in cGMPs.
  • Maintain up-to-date knowledge of USP, Ph Eur, JP and ICH regulations.
  • Review laboratory notebooks, logbooks, protocols and reports documents, as applicable.
  • Assist management during inspections and internal audits.
  • Work with QA, QC and MFG to help maintain validation compliance.
  • Work with clients to include teleconferences/meetings, exchange of data/information and analytical training.
  • Schedule use of equipment and coordination of instruments with QC and MFG, as necessary.
  • Perform other assigned work as directed by supervisor.

    Qualifications:

    The qualified candidate will have a college degree specializing in chemistry or biochemistry and a minimum of seven years' experience in a GMP laboratory setting, at least four of which have been spent in method development/validation activities. A strong understanding of chromatographic principles and ICH regulations is desired. Necessary technical skills include HPLC, GC, MS and headspace analysis. Other useful technical experience includes UV/Vis, FTIR, optical rotation and Karl Fisher. Strong organizational skills and writing habits are a necessity.

      This position is based in our Vista, CA facility.

      APC's success is predicated on its ability to recruit and retain highly qualified and motivated people in all areas of the company. APC is an equal opportunity employer and offers a competitive compensation and benefits package.

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