Sr. Scientist Bioanalytics (Deviations)
In this role, the Bioanalytics Senior Scientist will support compliance-related activities within the Bioanalytics department as well as support ongoing international process transfer and stewardship.
Independently, execute, direct and assist in functions supporting the Bioanalytics department. Duties include:
Lead and perform OOS/OOE/OOT investigations and deviations supporting Bioanalytics department operations Perform Change Control activities such as initiation, change phase management, and impact assessments supporting groups outside the Bioanalytics department Support ongoing analytical stewardship of international contract manufacturers Train on Bioanalytics methods to build a knowledge base to support compliance-related activities To support both domestic and international activities, working off shift or weekends may be necessary. Knowledge and familiarity of SAP systems, including Quality Module (QM). Knowledge and familiarity of LIMS systems (Labware Lims) Knowledge and familiarity of eSOPS and TEDI. Drive 5S and lean projects Ensure conformance to in-house specifications and GMPs Performs training of new associates Assist in troubleshooting problems on lab instruments and analytical methods Authors new and revises existing cGMP documents to ensure compliance Perform review and release of test work. Other duties as assigned Additionally, maintains GMP and GLP systems and environment, as well as ensures that all safety requirements are met for the lab areas.
Work with biohazardous agents such as human cells, Lentiviral Vector, Human AB serum. May need to adapt to changing work shifts, both swing and/or graveyard on very short notice May use a computer for extended periods (up to 6 hours) EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements BS or MS in biology, chemistry, biochemistry, microbiology or other related science. English Minimum of 5 years experience in the pharmaceutical/Biotechnology industries. Relevant experience would include:
execution of OOS/OOE/OOT investigations and understanding the Change Control process within a GMP environment, conducting QC testing, release testing, coordinating the activities of a QC laboratory, and experience with method transfer. Knowledge of cGMP, USP and FDA guidelines. Thorough knowledge of bioassay test methods, as appropriate. Knowledge of LIMS systems. Knowledge of Change Control systems, such as Agile PLM Knowledge of Quality Management Systems, such as Trackwise Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations. Detail-oriented with expertise in problem solving and solid decision making abilities. Strong written and verbal communication skills are essential.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Independently, execute, direct and assist in functions supporting the Bioanalytics department. Duties include:
Lead and perform OOS/OOE/OOT investigations and deviations supporting Bioanalytics department operations Perform Change Control activities such as initiation, change phase management, and impact assessments supporting groups outside the Bioanalytics department Support ongoing analytical stewardship of international contract manufacturers Train on Bioanalytics methods to build a knowledge base to support compliance-related activities To support both domestic and international activities, working off shift or weekends may be necessary. Knowledge and familiarity of SAP systems, including Quality Module (QM). Knowledge and familiarity of LIMS systems (Labware Lims) Knowledge and familiarity of eSOPS and TEDI. Drive 5S and lean projects Ensure conformance to in-house specifications and GMPs Performs training of new associates Assist in troubleshooting problems on lab instruments and analytical methods Authors new and revises existing cGMP documents to ensure compliance Perform review and release of test work. Other duties as assigned Additionally, maintains GMP and GLP systems and environment, as well as ensures that all safety requirements are met for the lab areas.
Work with biohazardous agents such as human cells, Lentiviral Vector, Human AB serum. May need to adapt to changing work shifts, both swing and/or graveyard on very short notice May use a computer for extended periods (up to 6 hours) EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements BS or MS in biology, chemistry, biochemistry, microbiology or other related science. English Minimum of 5 years experience in the pharmaceutical/Biotechnology industries. Relevant experience would include:
execution of OOS/OOE/OOT investigations and understanding the Change Control process within a GMP environment, conducting QC testing, release testing, coordinating the activities of a QC laboratory, and experience with method transfer. Knowledge of cGMP, USP and FDA guidelines. Thorough knowledge of bioassay test methods, as appropriate. Knowledge of LIMS systems. Knowledge of Change Control systems, such as Agile PLM Knowledge of Quality Management Systems, such as Trackwise Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations. Detail-oriented with expertise in problem solving and solid decision making abilities. Strong written and verbal communication skills are essential.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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