BD (Becton, Dickinson and Company) QC Biochemist in Kornye, Hungary
Job Description Summary
As directed by the QC Operation Supervisor, the Biochemist: Responsible for conducting quality analysis of bulk, in-process and finished goods under limited or no supervision following standard operating procedures. The Biochemist should demonstrate proficiency in applicable QC techniques, operation of relevant equipment and software packages associated with testing, data analysis, interpretation and reporting. QC Biochemist is able to perform troubleshooting, investigations, provide and follow corrective/preventive actions for failures and non-conformances.
Primary Responsibilities and Duties
Perform all assigned QC tests following analytical methods and procedures (qualitative and quantitative analysis of raw materials and bulk, in-process or finished goods) following analytical methods and procedures (such as Flow Cytometry or ELISA, WB (Western Blot) etc.) for products. This may require working with human blood, human or mammalian cell culture and/or animals and animal tissues.
Assures bulks and/or finished products conform to established specifications.
Reviews data on all QC testing as assigned. Performs investigation for atypical or Out of Specification (OOS) results and makes recommendations as appropriate.
Provides technical guidance to resolve issues and follow-up on actions.
Supports complaint investigations and report results.
Performs material transactions in SAP system.
Attending shift start up meetings and providing appropriate status follow-up.
Ensures that cleaning, maintenance and calibration of QC equipment take place according to schedule.
Ensures the required docs/records are available.
Assists in the development and evaluation of new procedures and techniques and analyzes existing methods to suggest improvements. Performs Engineering Change Orders (ECO's) as needed. Assists the Supervisor in the preparation / review policies/procedures
Provide recommendations to continuously improve product/process quality and enhance productivity, reduce cost, and increase production capability.
Training & Compliance:
Participates in assigned cross-training or off-site training as required. When experienced, helps new biochemists in area-specific trainings.
Maintains working knowledge of current industry and international standards. Keeps abreast of the US and non-US regulations affecting own area of supervision/management and complies with those regulations. May propose changes to BD practices and procedures to support compliance requirements. Communicates the need for compliance to member of own functional area. Brings regulatory compliance questions/issues to the attention of the next level of management.
Assures finished products conform to internal and government standards and satisfies ISO regulations.
Promotes a safe work environment. Keeps abreast of the basic requirements for safety compliance in own area of work and complies with those requirements. Thoroughly understands lab safety and hazardous waste management. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental, Health & Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor and Safety Officer(s) of all observed hazardous conditions or unsafe work practices.
May perform other related duties and assignments as required
Knowledge in the operation of related instrumentation such as Centrifuges, Biosafety hoods, and Flow Cytometers.
Proficiency in at least one applicable QC techniques and software packages associated with testing, data analysis, interpretation and reporting.
Knowledge of immunoassays related to cell biology applications: Cells immunophenotyping or ELISA & Western Blots.
Knowledge of general laboratory safety, biosafety procedures and standards.
Use of MS Windows and MS Office, database and information management systems.
Knowledge of ISO and H&S requirements.
Receives little to no instructions on routine work and general instructions on new assignments.
Fully Bilingual (English and Hungarian, written and spoken).
Apply principles of rational systems to solve problems and deal with a variety of variables
Advanced computer skills: Windows, word processing, experience with database and information management systems.
Proven troubleshooting skills for equipment assigned. Track record of root cause determination and effective corrective / preventive action implementation. Proven problem solving skills.
Effective skills on analytical thinking, problem solving.
Interpersonal skills, written and oral communication and planning/organization.
Effective presentation skills.
Demonstrated ability to follow established policies and procedures.
Demonstrated ability to keep neat, accurate, and complete records and logs.
Demonstrated ability to effectively work with and influence management in a cross-functional environment.
Requires a Bachelor Degree in a related scientific discipline (such as Biology, Microbiology or Medical Technology) and experience in a pharmaceutical/ biotechnology environment and/or medical technology laboratory or equivalent combination of related education and experience.
Primary Work Location
HUN Kornye - Uveggyar
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.