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Bristol-Meyers Squibb, Co.

Sr. Specialist, Quality Control Senior Lab Analyst (R1556195-en-us)

Pharmaceuticals

All

Yearly

No

Manati, Puerto Rico, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

*** 2nd SHIFT 2pm-10:30pm***

Education and Knowledge requirements:

  • 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

Major duties and responsibilities:

  • 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.

  • Evaluates workloads capacity to effectively meets multiple competing priorities and the analytical data to identify quality performance trends 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.

  • 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 calibrations, qualification, validation and troubleshooting. 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. Participates in process validation and analytical method transfers.

  • Recommends and executes changes to documents (e.g. SOP’s, protocols, monographs, etc.).

  • Handles laboratory samples and coordinates the external testing when tests can’t be performed (or is not recommended to be performed in-house).

  • Conducts safety audits and participates in other safety/environmental activities.

  • Participates in Production meetings and plans work of the area in coordination with Planning Department schedules to comply with BRP metrics.

  • Assists the supervisor in lots disposition, trend analysis, area performance metrics and Annual Product Review Reports

  • Assists in new laboratory personnel training.

  • 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 audit/investigations (e.g., reference standard and product log book audits, etc.).

  • 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.

  • Ensures consistency with other site procedures and/or specifications and compliance with BMS Policies and Guidelines.

  • Assures to be qualified and trained in the applicable procedures required for their jobs functions.

  • 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).

  • Performs other work-related activities as required.

BMSBL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.