Bristol Myers Squibb Company

Analytical Technical Service Specialist

Location
Manati, PR, United States
Posted
Sep 16, 2020
Ref
R1526687
Required Education
Bachelors Degree
Position Type
Full time
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.

Accountable for the evaluation and closing of QC and ATS Laboratory investigations (QE's) Change Control, Corrective Action Preventive Action (CAPA's) according to BMS procedures and policies to ensure that procedures in the laboratory comply with BMS policies. Leads and/or supports Operational Excellence initiatives within the ATS laboratories. This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Responsibilities:
  • Originates and implements QC / ATS Laboratory changes controls following BMS procedures and policies ensuring the accuracy of the information and closing within the established time frame.
  • Originates and implements corrective and preventive actions following BMS procedures and policies and closing them within the established time frame.
  • Leads and / or supports different Operational Excellence initiatives in the ATS Laboratory such as visual aids, 5'S, spaghetti diagram, standardize work, etc .
  • Leads the safety program within the ATS laboratories performing monthly audits and Job Hazard assessments.
  • Executes monthly area audits ensuring compliance with BMS procedures and policies.
  • Conducts complex Laboratory Investigations ensuring the identification of the root cause and corrective and preventive action to prevent re-occurrence
  • Establishes and monitors ATS laboratories area metrics.
  • Recommends and makes changes to documents (e.g. SOP's, protocols, Testing Standard, methods, monographs, etc.) and ensures that these documents are aligned with the cGMP practice and BMS policies and; verifies and ensures consistency with other sites procedures and/or specifications.
  • Provides training to new members on approved methods and procedures following applicable training SOP.
  • Reviews new drug product fillings to ensure are in accordance with current practices in the QC/ATS laboratory.
  • Reviews new products specification ensuring the generated data at site level, comply with the proposed specifications.
  • Leads and performs special projects.
  • Determines requirements for documentation, materials, trainings and equipment modifications within the laboratories during the new
    product introduction process.
  • Conducts internal audits in the ATS laboratory to ensure that the areas are in compliance with BMS procedures and policies.
  • Generates protocols, reports, technical assessments and technical memos.
  • Supports analytical method transfer as required.


Knowledge/Skill:
  • Bachelor Degree in Natural Sciences or Engineering
  • Minimum five (5) years of experience in a Quality Control / Analytical Laboratories
  • Broad knowledge of cGMP governmental regulations and guidelines , and the ability to interpret and apply them
  • Ability to communicate effectively with wide range of personnel, written and verbal
  • Strong technical writing and interpretation skills related to investigations and Regulatory Filings
  • Extensive knowledge with the use and interpretation of pharmacopeias such as USP/NF, EP, JP, British
  • Ability to create / organize cGMP systems and procedures based on regulatory compliance requirements
  • In depth analytical thinking, statistical analysis, problem solving and technical investigation skills.
  • Experience with analytical techniques such as HPLC, GC, UV, FTIR, CE, ELISA, UV, BIO-assays, Gels, TOC, etc.
  • Knowledge and experience of computer and appropriate software packages. (e.g., word processing, spreadsheets, Empower, communications like e-mail, LIMS, etc).
  • Knowledge to collect and document data and/or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.).
  • Knowledge of computers applications (Microsoft Word, Excel, Power Point)
  • Excellent interpersonal skills and team work oriented
  • Excellent communications skills in Spanish /English
  • Knowledge of statistical tools


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.