Chemist I

Quality & Compliance Rochester, Michigan


Description

Chemist I, Quality / Quality Control Laboratory, Michigan-Rochester

 

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide.  For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89.  Learn more at www.endo.com.

 

POSITION SUMMARY:

The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.  May participate in investigations.  Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.

 

ROLE AND RESPONSIBILITIES:

Analysis & Testing

  • Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. 
  • Uses laboratory software for analyses

Lab Equipment

  • Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
  • Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
  • Under close supervision, learns to troubleshoot basic instrument problems

Investigations

  • With guidance, participates in OOS/OOT/NOE and other investigations
  • Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor
  • May assist in drafting, editing, and reviewing SOPs and laboratory investigations

Training

  • Maintains assigned training records current and in-compliance
  • May assist in the training of less senior laboratory staff

Compliance

  • Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting
  • Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs
  • Follows internal processes related to controlled substances

Safety

  • Follows EH&S procedures to ensure a safe work environment
  • Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS

 

REQUIRED QUALIFICATIONS:

Education & Experience

  • Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. 
  • Some pharmaceutical laboratory experience preferred.

Knowledge

  • Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. 
  • Basic knowledge of wet chemistry techniques
  • Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS
  • Competency in Microsoft Office Suite

Skills & Abilities

  • Ability to display and analyze data in a logical manner
  • Good verbal and written communication skills as well as good computer skills
  • Attention to details and accurate record keeping
  • Establish and maintain cooperative working relationships with others
  • Solid organizational skills
  • Ability to take initiative, set priorities and follow through on assignments

 

PHYSICAL REQUIREMENTS:

  • Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.  Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
  • Must occasionally lift and/or move up to 15-25 lbs.
  • Ability to wear personal protective equipment, including respirators, gloves, etc. 
  • Specific visions abilities are required by this job include close vision and color vision
  • Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods

 

ADDITIONAL INFORMATION:

  • Afternoon shift premium is 10% (non-union positions only)
  • Midnight shift premium is 15% (non-union positions only)

 

 

Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.

 

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

 

*LI-ENDP