- 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)
Boehringer Ingelheim Pharma GmbH & Co. KG