Bristol-Myers Squibb Company

Quality Control Senior Analyst

Location
Manati, PR, United States
Posted
Aug 15, 2019
Ref
R1517351
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary:

Accountable for providing support on Analytical Laboratory resolutions of investigations of non-conforming results, and for ensuring Analytical Laboratory equipment calibrations, qualification, validation and troubleshooting. In addition is responsible for performing and reviewing chemical and physical testing of materials, and products (small molecules and large molecules) in accordance with BMS specifications/SOPs 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.

Responsibilities:

1. Participates and conducts resolution of investigations of non-conforming results which involves the following duties:
a) evaluate analytical data (situation causing the investigation, product trend and history, method validation, etc),
b) write investigation reports, discuss information with analytical development scientist and supervisors, ensure
root cause analysis is pursuit.
c) approve investigations as delegate from Supervisor when required.
2. Evaluates workloads capacity to effectively meets multiple competing priorities and the analytical data to identify quality performance trends
3. Processes and reports analytical data utilizing computer systems (e.g., Empower system, SAP, LIMS, etc.), verifies the data generated by other peers and evaluates data for trending.
4. Ensures the reliability of the analytical equipment and the integrity of the physical localities through the proper maintenance and housekeeping of the testing areas.
5. Performs laboratory equipment calibrations, qualification, validation and troubleshooting.
6. Maintains accurate records of all work performed and document testing results as per Good Documentation Practices and laboratory notebooks and worksheets as per QC SOP's.
7. Participates in process validation and analytical method transfers.
8. Recommends and executes changes to documents (e.g. SOP's, protocols, monographs, etc.).
9. Handles laboratory samples and coordinates the external testing when tests can't be performed (or is not recommended to be performed in-house).
10. Conducts safety audits and participates in other safety/environmental activities.
11. Participates in Production meetings and plans work of the area in coordination with Planning Department schedules to comply with BRP metrics.
12. Assists the supervisor in lots disposition, trend analysis, area performance metrics and Annual Product Review Reports.

13. Assists in new laboratory personnel training.
14. Participates in Company projects and programs, such as safety and environmental training, GMP's, SOP's and others as required.
15. Purchases and maintains inventory of required supplies (e.g., standards, reagents, etc.).
16. Conducts internal audit/investigations (e.g., reference standard and product log book audits, etc.).
17. Assists Laboratory Supervisor in the creation distribution of weekly schedule according manufacturing requirements or products deadlines and performs as the backup of the supervisor role on his/her absent.
18. Ensures consistency with other site procedures and/or specifications and compliance with BMS Policies and Guidelines.
19. Assures to be qualified and trained in the applicable procedures required for their jobs functions.
20. Performs testing for raw materials, packaging components, intermediate products, finished products, and ILQ's as per current monograph/testing methods, USP/ NF, EP, JP, proposed monograph or validation protocols (where applicable).
21. Performs other work-related activities as required.

Knowledge/Skill:
  • Bachelor Degree in Science with a major in Biochemistry, Chemistry Industrial Chemistry, Biology or Medical Technologist
  • Four (4) years of experience in the Bio Analytical or Analytical laboratory within pharmaceutical industry
  • Experience in handling and analysis of proteins and bio-molecules (small molecules and large molecules)
  • Knowledge of computer and appropriate software packages. (e.g., word processing, spreadsheets, empower, communications like e-mail, LIMS, etc)
  • Ability to collect and document data and or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.)
  • Ability to perform basic troubleshooting, PM and/or calibration of laboratory equipment (column care and use, tools, in-line filters, etc.)
  • In depth knowledge of a variety of analytical techniques such as: chromatography (HPLC, GC), UV, spectroscopy, titration, dissolution, SDS PAGE, IEF, Size homogeneity, capillary electrophoresis, osmometers, etc.
  • In depth knowledge for the use and interpretation of USP/NF
  • Knowledge and experience with QC SOP's, cGMP's, federal and other countries regulatory requirements, documentation procedures and company policies/procedures
  • Demonstrated analytical thinking, statistical analysis, problem solving and technical investigation skills
  • Ability to direct methods validations, equivalency and qualification requirements
  • Ability to write analytical investigations and other technical reports
  • Ability to interpret data and provide directions to others in laboratory troubleshooting and the resolution of lab investigations
  • Ability to approve analytical data for the final release of reports from the laboratory
  • Ability to adjust group testing schedule in order to meet the various testing requirements imposed by the changing demands in forecast and capacity constraints
  • 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
  • Be proficient in the revision of reports and other documentation prepared by technical teams and understand the Quality Assurance impact
  • Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary


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.