Accountable for performing and reviewing chemical and physical testing of materials and products (small molecules & large molecules) in accordance with BMS procedures and specifications and/or applicable compendia. This position must comply with all security guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required by the job function.
- Performs testing for raw materials, packaging components, intermediate products, finished products, and ILQ's as per current monograph/testing methods, USP, NF, proposed monograph or validation protocols (where applicable).
- Processes and reports analytical data utilizing computer systems (e.g., Empower system, SAP, LIMS, etc.) and verifies data generated by other peers.
- Evaluates and analyzes data to identify and understand quality performance trends.
- Ensures the reliability of the analytical equipment and the integrity of the physical localities through the proper maintenance and housekeeping of the testing areas.
- Performs laboratory equipment daily calibrations, verifications, qualification, validation and troubleshooting.
- Maintains accurate records of all work performed and document testing results as per Good Documentation Practices and of all laboratory notebooks and worksheets as per QC SOP's.
- Participates in process validation, laboratory equipment qualification, and analytical method transfers.
- Recommends change to SOP's, protocols, monographs, etc.
- Provides support in the investigations of non-conforming results and resolution of investigations.
- Assists in new laboratory personnel in training when required.
- Follows laboratory SOPs for sample handling and the proper management of data generated.
- Participates in Company projects and programs, such as safety and environmental training, GMP's, SOP's and others as required.
- Purchases and maintains inventory of required supplies (e.g., standards, reagents, etc.).
- Conducts internal audits (e.g., laboratory facilities, reference standard, reagents and product log book audits, etc.).
- Ensures that use approved validated methods and specifications, to perform required testing when is involved in testing of finished products, API's, biological drug substances, raw materials, intermediates / components and ensures all necessary testing is carried out.
- Ensures that the QC equipment that will use and that he/she are formally qualified before release testing of products/materials is performed.
- Ensures that stability studies testing follow specific protocols and procedures.
- Verifies that Laboratory procedures and specifications are consistency with other site procedures and/or specifications and; that are in compliance with BMS Policies and Guidelines.
- Completes all required testing on time dictated by SAP and area cycle time requirements in compliance with company and regulatory requirements.
- B.S. degree in Science with a major in Chemistry, Biochemistry, Industrial Chemistry, Biology or Medical Technology
- One (1) year of experience in a Pharmaceutical environment
- Working knowledge of computer and appropriate software packages. (e.g., word processing, spreadsheets, Empower, communications like e-mail, LIMS, etc)
- Knowledge on analytical data collection and documentation or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.)
- Knowledge of laboratory equipment, such as: UV-Visible, FTIR, HPLC, GC, CE, Scanners, micro plate readers
- Ability to perform basic troubleshooting, PM and/or calibration of laboratory equipment (column care and use, tools, in-line filters, etc.)
- Ability to conduct a variety of analytical techniques
- Knowledge of site safety, security and environmental requirements (e.g. MSDS, safety inspection checklists, waste disposal, etc.)
- In-depth knowledge in the use and interpretation of USP/NF
- Basic knowledge and experience with QC SOP's, cGMP's, federal and other countries regulatory requirements, documentation procedures and company policies/procedures
- Working knowledge of statistical techniques.
- Ability to work in a teamwork environment
- Ability to plan work schedules and set priorities with urgency and meet deadlines within a complex, rapidly changing environment
- Proficiency in oral and written communication skills in both, English and Spanish
- Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary