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Baxter International Inc. · 2 days ago

Senior Manager, Sterility Assurance,

Marion, NC

Full-time

Onsite

Senior Level

$136K/yr - $187K/yr

7+ years exp

Baxter International Inc. is dedicated to redefining healthcare delivery and making a significant impact in the lives of individuals. The Senior Manager, Sterility Assurance will ensure compliance with contamination control requirements and drive continuous improvement initiatives within the Sterility Assurance Program.

BiotechnologyClinical TrialsHealth CareMedical

No H1B

Responsibilities

Develop, implement, and drive continuous improvement initiatives within the Sterility Assurance program

Recognizes and assures conformance to regulations applicable to sterility assurance. Serve as Sterility Assurance SME 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

Qualification

Sterility AssuranceMicrobiological ExpertiseCGMP KnowledgeContamination ControlAseptic TechniqueTechnical WritingProject ManagementTroubleshooting SkillsProblem-Solving MethodologiesCommunicationLeadership Experience

Required

Bachelor's Degree in Microbiology, Biology, or related science

Minimum 7 years' confirmed experience in cGMP related industry, with minimum five years' experience in sterility assurance

Minimum 5 years' 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 interacting with FDA or similar regulatory agencies

Benefits

Medical, Dental and Vision coverage

160 hours of Paid Time Off and Paid Holidays

401K match

Employee Stock Purchase Program

Paid Parental Leave

Tuition Reimbursement

Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance

Flexible Spending Accounts

Educational assistance programs

Family and medical leaves of absence

Commuting benefits

The Employee Discount Program

The Employee Assistance Program (EAP)

Childcare benefits

Company

Baxter International Inc.

Glassdoor3.7

For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world.

Founded in 1931

Deerfield, Illinois, USA

10001+ employees