Responsible for performing analytical test to laboratory samples to determine its conformance with established specification. This responsibility includes the testing of materials associated to their area (such as In-Process, Raw Materials, Packaging Components, Stability, Finished Goods and Drug Laboratory samples). Also, is responsible for standardization of solutions and calibration, qualification and validation of sophisticated instruments and methods. Responsible for the safe execution of the assigned tests procedures and proper documentation according to the applicable Quality Standard (QS) procedures and/ or company policies. Knowledgeable of Regulated Laboratory Environment and cGMPs, FDA and DEA guidance. Review analytical and cGMP data and lot releases when required. Coordination of laboratory activities and participate in Tiers when needed. Will ensure Site’s business continuity by providing on-time required Laboratory services.
Education and/ or Experience
- Bachelor’s Degree in chemistry
- At least one (1) year of laboratory experience.
Licenses and/ or Certifications
- Puerto Rico Chemist license is required. (Responsible to keep updated)
- Licenses to manage explosive materials, preferred.
- Working shifts (including weekends).
- Testing of laboratory samples from different sources according to the existing and applicable standards and regulations.
- Troubleshooting of methods and/ or instruments when needed. Carries out special assignment within the area of responsibility such as the development of better test procedures and troubleshooting to make recommendations based on his/her findings.
- Responsible for the interpretation and compliance of QS, procedures, and company policies as well as reviews and evaluates QS, testing guidelines, SOP’s and policies and provides feedback in timely manner.
- Conduct laboratory investigations as part of the non-conforming results reporting. Interpretation and reporting of product laboratory results.
- Prepares and standardizes laboratory solutions for use in laboratory testing. Performs internal verification, as necessary, to laboratory equipment to assure that all results obtained are reliable.
- Document all laboratory records complying with applicable procedures and current Good
- Manufacturing Practices (cGMP’s) as well as DEA regulations.
- Responsible for the Data entry in the various systems such as laboratory instrumentation, LIMS and SAP.
- Qualification and training of peers. Will help to maintain laboratory housekeeping and organized.
- Informs the supervisor of the status of the operation and reports any unusual situation and or problem.
- Handles routine matters independently.
- Reviews the analytical data developed by a first analyst to be in accordance with the acceptance criteria and specifications of procedures.
- Participates in the transfer of new technology and analytical methods to the laboratory.
- Manage, store, handle, dispose, label and inspect laboratory waste following EPA, EQB and site: requirements procedures, guides, and policy. Adheres to all safety requirements in handling toxic and reactive chemicals, testing reagents, glassware, and equipment
- Comply with all environmental trainings, procedures, guidelines, practices, cGMP’s, permit conditions and internal notifications of any environmental event.
- Perform any other job-related duties as required or that may arise in the future.
- Fully bilingual (Spanish and English)
- Knowledge of Good Manufacturing Practices, Good Laboratory Practices, DEA, Safety, EPA and OSHA regulations and rules.
- Knowledge of a wide variety of analytical, chemical and automation disciplines.
- Knowledge and ability to work with computers and computer-based software.
- Able to work under pressure, self-starter and able to handle multiple priorities with minimum supervision.