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
Bristol Myers Squibb