Bristol-Myers Squibb Company

Senior Incoming Laboratory Analyst

Location
Manati, PR, US
Posted
Oct 12, 2018
Ref
R1510748
Required Education
Bachelors Degree
Position Type
Full time
Summary:

Provides support to the area supervisor in the coordination of the Incoming Laboratory activities and duties that require a Chemist license in addition to perform and review sampling, inspection, and testing related to Raw Materials/Excipients, Active Product Ingredients (API), sterile materials and Packaging Components received at BMS Manati and assuring compliance with applicable regulations (EU, Japan, Brazil, FDA requirements). This position must to comply with the Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job.

Responsibilities:

1. Performs testing, sampling and inspection for raw materials/excipients, packaging components, intermediate products, retain samples , finished products and Inter Laboratory Qualifications as per current Testing Standards and/or monograph, USP, NF or validation protocols (where applicable).
2. Performs the disposition of raw materials/excipients, active product ingredients (API) and packaging components according to results obtained.
3. Performs investigations of non-conforming results and resolution of investigations.
4. Performs and review required testing of materials and products in accordance with BMS specifications and/or applicable compendia.
5. Leads process validations, laboratory equipment qualifications, and method transfers activities.
6. Initiates and provides follow up to completion of change control for Testing Standard, methods and or equipments (new or retirement).
7. Recommends and make changes to documents such as: SOPs, protocols, methods, operational procedures, etc.
8. Approves cleaning records performed on Incoming API Sampling and Raw Material Incoming Sampling Rooms.
9. Provides training support for Manufacturing and QA personnel (e.g., expiration dating SOP, etc.) and to new members on approved monographs and procedures following applicable training SOP.
10. Conducts internal audits (e.g., housekeeping, logbook audits, etc.).
11. Assists Incoming Laboratory Supervisor in the creation, distribution of weekly schedule according manufacturing requirements or products deadlines. .
12. Coordinates laboratory schedule, approve laboratory investigations and inform management during the Laboratory supervisor absence such as sick period or vacations.
13. Represents Incoming Supervisor in Production Meetings and work plans of the area in coordination with Planning Department schedules to comply with area metrics.
14. Provides support in the approval of final Certificate of Analysis generated by the area or Product Release for raw materials, packaging components or finished products manufactured at BMS Manati.
15. Ensures that have approved validated methods and specifications, robust systems and adequate facilities 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.
16. Assures to be qualified in the QC equipment that will use and that the equipment is formally qualified before release testing of products/materials.
17. Verifies consistency with other site procedures and/or specifications and verifies compliance with BMS Policies and Guidelines.

Knowledge/Skill:
• B.S. Degree in Natural Sciences .
• Three (3) years of experience within Quality Control Laboratory in a Pharmaceutical Industry.
• Knowledge of computer and appropriate software packages. (e.g., word processing, spreadsheets, Empower, communications like e-mail, LIMS, etc)
• Proven knowledge to collect and document data and or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.).
• Ability to perform troubleshooting, PM and/or calibration of laboratory equipment (column care and use, tools, in-line filters, etc.).
• 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 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 conduct a variety of analytical techniques.
• Ability to evaluate and analyze data to identify and understand quality performance trends.
• 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.