Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Performs disposition for raw materials (RM) / excipients / Active Pharmaceutical Ingredients (API) / Drug Substances (DS).
Performs review and disposition for packaging components, including visual, dimensional and functional tests.
Performs review and disposition for sterile materials, sterile garments and material requirement sheet. Supports Material/Laboratory Qualifications as per current Testing Standards and/or monograph, USP, NF or validation protocols (where applicable).
Performs investigations of non-conforming results and resolution of investigations.
Performs and reviews required testing of materials and products in accordance with BMS specifications and/or applicable compendia.
Provides follow up to completion of change control for Testing Standard, methods and or equipments (new or retirement).
Recommends and make changes to documents such as: SOPs, protocols, methods, operational procedures, etc.
Approves cleaning records performed in Incoming API Sampling and Raw Material Incoming Sampling Rooms.
Assists in processing and reporting analytical data utilizing computer systems (e.g. TrackWise (TW), Infinity, Maximo, Ariba, SAP, LIMS, Scan TVS Proof Reader, Vision System, Bluehill Software, etc.) and verifies data generated by Incoming Analysts.
Approves change request to create new items in LIMS system. Understands the operation of laboratory equipment, such as: Ruler, Caliper, Instron, Optical Comparator, Vision System, Scan TVS, Barcode Reader (Cognex), Micrometers, gauges, Go-No Go gauges and others.
Recommends and make changes to documents such as: SOPs, protocols, methods, work instructions, operational procedures, etc. Provides training to new members in applicable OJT, tasks and SOPs.
Conducts internal audits (e.g., housekeeping, logbook audits, etc.). Assists Incoming Laboratory Supervisor in the creation, distribution of weekly schedule according manufacturing requirements or products deadlines.
Coordinates laboratory schedule, approve laboratory investigations and inform management during the Laboratory supervisor absence such as sick period or vacations.
Represents Incoming Supervisor in Production Meetings and work plans of the area in coordination with Planning Department schedules to comply with area metrics.
Ensures that have approved validated methods and specifications, robust systems and adequate facilities to perform required testing when is involved in testing of packaging components and ensures all necessary testing is carried out.
Verifies consistency with other site procedures and/or specifications and verifies compliance with BMS Policies and Guidelines.
Coordinates the required testing with Microbiology and /or Analytical Laboratory corresponding to Active Product Ingredients, excipients and packaging components.
Coordinates sampling and sample delivery to outside laboratories for testing that cannot be performed in-house.
Ensures that approved validated methods and specifications, robust system and adequate facilities are used to perform requires testing for RM, API, Excipients, Drug Substances, Packaging Components among others.
Performs material status changes in SAP according to applicable procedures. Generates Work order in Maximo system for equipment repairs, facility repairs, etc. Tracks materials status through the QA 33 report from SAP to maintain Incoming Attainment metrics within business goals. Directs daily Tier 1 meeting.
Education and Skill Requirements:
B.S. Degree in Natural Sciences.
Three (3) years of experience within Quality Control Laboratory in a Pharmaceutical Industry.
Working knowledge of computer and appropriate software packages. (e.g., Trackwise, SAP, LIMS and Microsoft Office (Word , Excel, Power Point)
Proven knowledge to collect and document data and or other information (e.g. significant figures, rounding off rules, etc.).
Ability to perform basic troubleshooting of Incoming Laboratory equipment including but not limited to system check, setting and daily verification.
Knowledge of site safety, security and environmental requirements (e.g. SDS, safety inspection checklists, waste disposal, etc.)
In-depth knowledge in the use and interpretation of USP/NF and a working knowledge of QC SOP’s, cGMP’s, federal and other countries regulatory requirements.
Knowledge and experience with QC SOP’s, cGMP’s, federal and other countries regulatory requirements, documentation procedures and company policies/procedures.
Ability to understand a variety of analytical techniques.
Ability to evaluate and analyze data to identify discrepancies
Knowledge and working experience applying statistical techniques.
Ability to review data generated of peers.
Ability to plan work schedules and set priorities with urgency and meet deadlines within a complex, rapidly changing environment.
Ability to resolve complex problems that arise utilizing techniques in methods development, troubleshooting and optimization phases.
Proficiency in oral and written communication skills in both, English and Spanish.
Capacity to communicate in an effective way with other departments to reach agreements.
Knowledge of applicable sampling plans (e.g., ANSI/ASQ Z1.4 /Z1.9).
Proven knowledge of the SAP System.
Good organizing, planning and leadership skills.
Capacity to use Safety Respirator and capacity to perform the Safety gowning.
Willing to work irregular hours, rotation shifts, weekends, and holidays, when necessary.
Inspection tasks require 20/20 visual eye accuracy and color detection with or without correction
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.