Aseptic Process Support Senior Specialist
- Manatí, Puerto Rico
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.
Lead the media fill and smoke profiles matrix execution.Accountable for the evaluation and closing of Aseptic Processing Investigations, change control, corrective action, preventive action (CAPAs) 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 Microbiology laboratory. This position must comply with all security guidelines, Environmental health and safety regulations and the current Good manufacturing Practices required by the job function.
Major Duties and Responsibilities:
1. Leads the Media Fill activities in order to assure that typical and atypical interventions are performed as established and that new ones are evaluated and integrated as required.
2. Helps to ensure the aseptic techniques, cleaning and sanitization validations for clean rooms and isolators, HEPA Filter and Gowning process are adequate and effective.
3. Interfaces directly with manufacturing operations to ensure that appropriate environmental and aseptic procedures are in place, through the execution of thorough reviews of procedures against practice.
4. Lead and executes smoke profiles tests.
5. Leads the Environmental Review Committee and provides scientific guidance in decision-making issues.
6. Assures that the manufacturing operations (Parenteral and / or Oral Solid Dosage) are performed in compliance with domestic and international cGMP regulations, and BMS policies and procedures
7. Originates, evaluates and implements Microbiology Laboratory Change Controls following BMS procedures and policies ensuring the accuracy of the information and closing with established period.
8. Originates and implements corrective and preventive actions following BMS procedures and policies and closing them within the established period.
9. Leads the clean rooms classifications qualifications and re-qualifications.
10. Leads aseptic processing special projects to accomplish company goals and objective on a timely and effective manner.
11. Participates in the critical review of all documents associated with the manufacturing aseptic processing.
12. Leads media fill APQR.
13. Provides formal presentations to upper management on environmental monitoring trends and aseptic processing status and opportunities, as applicable.
14. Leads different Operational Excellence initiatives in the Microbiology Laboratory such as visual aids, 5's, spaghetti diagram, standardize work, etc.
15. Conducts complex Microbiology laboratory Investigations ensuring the identification of the root cause and the corrective end preventive action to prevent re-occurrence.
16. Recommends and make changes to documents (e.g. SOP's, protocols, Testing Standards, methods, monographs, etc.) and ensures consistency with other sites procedures and/or specifications.
17. Reviews new drug product filings to ensure are in accordance with current practices in the Microbiology lab and regulatory requirements.
18. Reviews new product specification ensuring the generated data at site level, comply with the proposed specifications.
19. Leads and perform special projects.
20. Determines requirements for documentation, materials, trainings, and equipment modifications related to aseptic processing manufacturing the during the new product introduction process.
21. Conducts internal audits in the Microbiology Lab to ensure that the areas are in compliance with BMS procedures and policies.
22. Generates protocols, reports, technical assessments, risk assessments and technical memos with scientific acumen using statistical tools and regulatory guidance.
- Bachelor Degree in Natural Sciences or Engineering
- Minimum eight (8) years of experience in Microbiology lab with at least five (5) years' experience with the Aseptic Processing field.
- 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 skills.
- Experience with Aseptic Processing Techniques.
- Knowledge and experience of computer and appropriate software packages (e.g., word processing, spreadsheets, communications like e-mail, LIMS, etc.).
- Knowledge to collect and document data and /or other information (e.g. significant figures, rounding off rules, etc.).
- Knowledge of computers applications (Microsoft Word, Excel, Power Point).
- Excellent interpersonal skills and teamwork 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.
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