Baxter
Sr Sterility Assurance Manager
Baxter, Marion, North Carolina, United States, 28752
This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives - where your purpose accelerates our mission.Your role at BaxterThis is where your creativity addresses challengesThis role is to ensure site policies, programs, procedures, and practices are in place to meet established requirements for contamination control of clean-rooms, manufacturing processes, and products. To implement and drive continuous improvement initiatives within the Sterility Assurance Program.Your Team at BaxterWithin Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.What we offer from Day OneMedical, Dental and Vision coverage160 hours of Paid Time Off and Paid Holidays401K matchEmployee Stock Purchase ProgramPaid Parental LeaveTuition ReimbursementWhat you'll be doing:Develop, implement, and drive continuous improvement initiatives within the Sterility Assurance programRecognizes and assures conformance to regulations applicable to sterility assurance. Serve as
STERILITY ASSURANCE SUBJECT MATTER EXPERT
during routine audits by regulatory agencies, internal corporate auditors, and external auditors.Provide microbiological expertise including, but not limited to, SOPs, change control, and validations.Assist in the development, documentation, and management of the site contamination control strategy.Through continuous improvement efforts, work to prioritize and improve cleaning procedures across multiple operating lines and areas.Provide oversight and Sterility Assurance expertise to Operations to assure all applicable regulatory requirements are met.Write, review, and/or approve environmental cleaning protocols to support cleaning practices.Design and implement training program(s) for cleanroom behavior and contamination control practices.Responsible for the microbiological/sterility assurance risk assessment.Support ongoing projects throughout the facility by completion of environmental FMEAs, assessing potential impact of proposed changes, supplying to the design of projects, and performing risk assessments.Coordinate responses to environmental and process conditions detected during Real Time Risk Assessments (RTRA).Perform and/or participate in root cause investigations for microbiological and manufacturing nonconformances. Collaborate with microbial investigators and manufacturing compliance teams to resolve potential CAPA items in response to microbial out of limits.Establish appropriate response plans to environmental events in clean-rooms.Write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews.Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement.Work in partnership with regional sterility assurance authorities to achieve company objectives and ensure policy alignment across site.What you'll bring:Bachelor's Degree in Microbiology, Biology, or related science.Seven (7) to 10 years confirmed experience in cGMP related industry.FIVE (5) OR MORE YEARS OF WORK EXPERIENCE IN STERILITY ASSURANCE REQUIRED.Five (5) or more years of proven leadership/supervision and experience within an aseptic or sterile manufacturing site.Knowledge of aseptic and terminal sterilization processing.Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.).Knowledge of standard microbiological procedures (environmental monitoring, bioburden, bacterial endotoxin testing).Knowledge of FDA cGMP, EU Annex-I, ISO 14644-1 standards.Expert knowledge in aseptic technique, clean-room behavior and practice, cleaning methodologies, and risk assessments.Strong communication and project management skills.Must have good analysis, troubleshooting, and investigative skills including knowledge and understanding of problem-solving methodologies (DMAIC, Ishikawa Diagram).Must have strong technical writing skills and ability to put thoughts and issues into writing in such a manner to be understood by the reader.Able to confidentially interact with FDA or similar regulatory agencies.Other Duties as AssignedPlease note this job description is not crafted to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as needed.Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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STERILITY ASSURANCE SUBJECT MATTER EXPERT
during routine audits by regulatory agencies, internal corporate auditors, and external auditors.Provide microbiological expertise including, but not limited to, SOPs, change control, and validations.Assist in the development, documentation, and management of the site contamination control strategy.Through continuous improvement efforts, work to prioritize and improve cleaning procedures across multiple operating lines and areas.Provide oversight and Sterility Assurance expertise to Operations to assure all applicable regulatory requirements are met.Write, review, and/or approve environmental cleaning protocols to support cleaning practices.Design and implement training program(s) for cleanroom behavior and contamination control practices.Responsible for the microbiological/sterility assurance risk assessment.Support ongoing projects throughout the facility by completion of environmental FMEAs, assessing potential impact of proposed changes, supplying to the design of projects, and performing risk assessments.Coordinate responses to environmental and process conditions detected during Real Time Risk Assessments (RTRA).Perform and/or participate in root cause investigations for microbiological and manufacturing nonconformances. Collaborate with microbial investigators and manufacturing compliance teams to resolve potential CAPA items in response to microbial out of limits.Establish appropriate response plans to environmental events in clean-rooms.Write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews.Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement.Work in partnership with regional sterility assurance authorities to achieve company objectives and ensure policy alignment across site.What you'll bring:Bachelor's Degree in Microbiology, Biology, or related science.Seven (7) to 10 years confirmed experience in cGMP related industry.FIVE (5) OR MORE YEARS OF WORK EXPERIENCE IN STERILITY ASSURANCE REQUIRED.Five (5) or more years of proven leadership/supervision and experience within an aseptic or sterile manufacturing site.Knowledge of aseptic and terminal sterilization processing.Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.).Knowledge of standard microbiological procedures (environmental monitoring, bioburden, bacterial endotoxin testing).Knowledge of FDA cGMP, EU Annex-I, ISO 14644-1 standards.Expert knowledge in aseptic technique, clean-room behavior and practice, cleaning methodologies, and risk assessments.Strong communication and project management skills.Must have good analysis, troubleshooting, and investigative skills including knowledge and understanding of problem-solving methodologies (DMAIC, Ishikawa Diagram).Must have strong technical writing skills and ability to put thoughts and issues into writing in such a manner to be understood by the reader.Able to confidentially interact with FDA or similar regulatory agencies.Other Duties as AssignedPlease note this job description is not crafted to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as needed.Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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