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Online Laboratory Magazine
04/18/2021

Chemist (m/f/d)


  • Performs the testing of laboratory samples. Interprets, executes and ensures compliance with Quality Standards (QS), pharmacopoeias, procedures and company policies.
  • Interprets and documents product laboratory results complying with applicable procedures and cGMP.
  • Timely review and/or approval testing results as required.
  • Conducts laboratory investigations as part of the non-conforming results reporting. Act as investigator, technical support or reviewer/approver as assigned.
  • Executes troubleshooting of methods and /or instruments as needed.
  • Performs internal verification, as necessary, to laboratory equipment to assure that all results obtained are reliable.
  • Performs data entry in the various systems such as laboratory instrumentation, Trackwise, GBS (SAP) and LIMS. Act as key user for systems if assigned by Supervisor.
  • Provides support in the qualification and training of laboratory analysts.
  • Assist maintaining good housekeeping. Adheres to all safety requirements in handling toxic and reactive chemicals, testing reagents, glassware and equipment.
  • Informs the supervisor on the status of the operation and reports any unusual situation and or problem.
  • Reviews and evaluates QS, testing guidelines, SOP's and policies and provides feedback in a timely manner.
  • Performs internal notification of any environmental event, such as malfunction, spill or any other.
  • Participate in special projects as assigned by the Supervisor. Carries out special assignment such as the development of better test procedures and troubleshooting to make recommendations based on findings.
  • Reviews the analytical data developed by a first analyst to be in accordance with the acceptance criteria and specifications of procedures.
  • Segregates, performs inspection, labeling and handles waste such as biomedical, non-hazardous and hazardous material.
  • Participates in the analytical method transfer, validation, verification and familiarization for new products. Supports activities associated to transfer of new technology and automated systems.
  • Complies with training on cGMPs, safety/environmental, procedures, guidelines, policies and forms.
  • Acts as Quality System Subject Matter Expert (SME) as assigned.
  • Bachelor Degree in Chemistry
  • At least two (2) years of laboratory experience
  • Available to work irregular, extended or rotating shifts if needed.
  • Puerto Rico Chemist license is preferred. Responsible to keep updated.
  • License to handle explosive material (when required by the PRPD)
  • Knowledge of pertinent regulations, particularly those related to the good manufacturing practices and good laboratory practices (including USP, EP, JP and other applicable compendium.
  • Knowledge of Good Manufacturing Practice regulations, EPA regulations, Safety Rules, OSHA rules, classical and modern analytical chemistry and sophisticated instrumental techniques.
  • Ability to read and interpret documents such as safety rules, policies, manuals, and procedures
  • Technical writing skills as well as experience reviewing chemical procedures and technical investigation reports are a must.
  • Strong understanding of CFR 21, FDA and EU regulations among others.
  • Able to work in standing position for long period of time performing testing
  • Able to handle laboratory equipment, tools and utensils
  • Physical effort to handle laboratory equipment, solution containers, glassware
  • Walk through the micro laboratory area
  • Operate laboratory equipment.
  • Visual capacity to perform micro testing is required
  • Able to visually differentiate
  • Adequate odor perception
  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)


» Job description


Employer:
Boehringer Ingelheim Pharma GmbH & Co. KG
Location:
Barceloneta [PRI]