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Sterility Assurance Manager I

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Baxter International Inc.

1mo ago

  • Job
    Full-time
    Senior & Expert Level
  • Hickory

AI generated summary

  • You need a Bachelor’s in Microbiology/Biology, 7-10 years in cGMP, 5+ years in sterility assurance, leadership experience, knowledge of aseptic processes, and strong communication skills.
  • You will drive continuous improvement in Sterility Assurance, ensure regulatory compliance, provide microbiological expertise, and oversee cleaning protocols and training in cleanroom practices.

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 role of a Sterility Assurance Manager I at Baxter?

The Sterility Assurance Manager I is responsible for ensuring that site policies, programs, procedures, and practices are in place to meet established requirements for contamination control in clean-rooms, manufacturing processes, and products.

What qualifications are required for this position?

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

What kind of benefits does Baxter offer from day one?

Baxter offers medical, dental, and vision coverage, 160 hours of paid time off and holidays, 401K match, employee stock purchase program, paid parental leave, and tuition reimbursement.

Will I be working alone or as part of a team?

You will be working as part of a team within the Quality department, collaborating with various individuals to address challenges and improve processes.

Is experience in regulatory audits important for this role?

Yes, significant experience is critical as the Sterility Assurance Manager I will serve as a Subject Matter Expert during routine audits by regulatory agencies, internal corporate auditors, and external auditors.

What specific knowledge is essential for this position?

Knowledge of aseptic and terminal sterilization processing, contamination control practices, standard microbiological procedures, FDA cGMP, EU Annex-I, and ISO 14644-1 standards is essential.

What are the expected salary ranges for this position?

The estimated base salary for this position ranges from $104,000 to $143,000 annually, depending on factors such as location, skills and expertise, and experience.

What kind of additional skills are desirable for a candidate?

Strong communication and project management skills, good analysis and troubleshooting abilities, as well as technical writing skills, are desirable for the position.

Is COVID-19 vaccination required for this role?

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

How does Baxter ensure equal employment opportunities?

Baxter is committed to equal opportunity employment and 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.

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.