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Sterility Assurance Manager I

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Baxter International Inc.

1mo ago

  • Job
    Full-time
    Senior & Expert Level
  • Asheville

AI generated summary

  • You need a relevant degree, 7-10 years in cGMP, 5+ years in sterility assurance, leadership experience, and knowledge of aseptic techniques, contamination control, and regulatory standards.
  • You will drive sterility assurance initiatives, ensure compliance, provide microbiological expertise, oversee cleaning protocols, conduct training, and perform risk assessments while supporting operations.

Requirements

  • * Bachelor’s Degree in Microbiology, Biology, or related science.
  • * Seven (7) to 10 years confirmed experience in cGMP related industry, with five (5) or more years of work experience in sterility assurance.
  • * 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 interacting with FDA or similar regulatory agencies.

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.

FAQs

What is the primary responsibility of the Sterility Assurance Manager I at Baxter?

The primary responsibility is to ensure that site policies, programs, procedures, and practices are in place to meet established requirements for contamination control of cleanrooms, manufacturing processes, and products.

What qualifications are required for this position?

Candidates must have a Bachelor’s Degree in Microbiology, Biology, or a related science, along with seven to ten years of confirmed experience in a cGMP-related industry, including five or more years in sterility assurance.

What types of initiatives will the Sterility Assurance Manager I be involved in?

The manager will develop, implement, and drive continuous improvement initiatives within the Sterility Assurance program.

Are there opportunities for training in this role?

Yes, the position involves designing and implementing training programs for cleanroom behavior and contamination control practices.

How does Baxter ensure compliance with regulations in this role?

The Sterility Assurance Manager I will serve as a Subject Matter Expert (SME) during routine audits by regulatory agencies, internal corporate auditors, and external auditors to ensure conformance to applicable regulations.

What experience in leadership is required for this position?

Candidates must have five or more years of proven leadership or supervision experience within an aseptic or sterile manufacturing site.

What kind of support does Baxter provide to employees?

Baxter offers medical, dental, and vision coverage, paid time off, a 401K match, employee stock purchase programs, tuition reimbursement, and paid parental leave.

Is technical writing a necessary skill for the Sterility Assurance Manager I?

Yes, strong technical writing skills are essential, as the candidate must be able to clearly convey ideas, thoughts, and issues in writing for better understanding.

How does Baxter handle compensation for this role?

The estimated base salary for this position ranges from $104,000 to $143,000 annually, with compensation based on factors like location, skills, experience, and market data.

Are there any vaccination requirements for this job?

Yes, the successful candidate may be required to verify COVID-19 vaccination status, subject to reasonable accommodations for medical conditions or religious beliefs.

Baxter International Inc.

Saving and Sustaining Lives

Science & Healthcare
Industry
10,001+
Employees
1931
Founded Year

Mission & Purpose

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. We believe every person — regardless of who they are or where they are from — deserves a chance to live a healthy life, free from illness and full of possibility. At the intersection of progress and purpose is where we are redefining what it means to be a global medtech leader. It is where we are relentlessly pursuing healthcare transformation, fueled by our compassion for patients and providers and the challenges they face. It is where bold ideas meet the promise for meaningful change in the world around us. We are there, at every step of the journey, to help clinicians deliver the best care possible.

Benefits

  • Medical Coverage is available for employees and eligible family members. Employees can choose from a variety of medical plan options, balancing cost and features that best meet their needs.

  • Dental Coverage is offered separately from medical coverage, so employees may elect one without electing the other. Employees have a choice of dental plan options and coverage is also available for eligible family members.

  • Baxter provides Basic Life Insurance, Short-Term Disability, Basic Long-Term Disability and Business Travel Accident insurance at no cost to employees immediately upon hire.

  • Paid Time Off of 20 to 35 days based on length of service. Flexibility to manage your time off and use your days as you choose (vacation, personal, sick all combined into one “pool of days”).

  • Paid Parental Leave provides 12 weeks of paid time off for new mothers and fathers.