Manager, PCI Compliance Assurance
CVS HealthSalary not specified
Senior Manager, Sterility Assurance/Micro (7am-3pm) at Baxter International
Marion, North Carolina, United States
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical DevicesIndustries
Requirements
- Expertise in sterility assurance and microbiology, serving as SME during audits by regulatory agencies, internal corporate auditors, and external auditors
- Knowledge of regulations applicable to sterility assurance
- Ability to provide microbiological expertise for SOPs, change control, and validations
- Capability to develop, document, and manage site contamination control strategy
- Experience in continuous improvement efforts, including prioritizing and improving cleaning procedures
- Skills in conducting microbiological/sterility assurance risk assessments, environmental FMEAs, and risk assessments for projects
- Proficiency in root cause investigations for microbiological and manufacturing nonconformances, and resolving CAPA items
- Ability to write, review, and approve environmental cleaning protocols and Standard Operating Procedures (SOPs)
- Experience in designing and implementing training programs for cleanroom behavior and contamination control
- Capability to perform GEMBA style assessments of manufacturing operations
Responsibilities
- Develop, implement, and drive continuous improvement initiatives within the Sterility Assurance program
- Ensure site policies, programs, procedures, and practices meet requirements for contamination control of clean-rooms, manufacturing processes, and products
- Recognize and assure 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 SOPs, change control, and validations
- Assist in the development, documentation, and management of the site contamination control strategy
- Prioritize and improve cleaning procedures across multiple operating lines and areas through continuous improvement efforts
- Provide oversight and Sterility Assurance expertise to Operations to assure 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
- Conduct microbiological/sterility assurance risk assessments
- Support ongoing projects by completing environmental FMEAs, assessing impacts of changes, contributing to project design, 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, collaborating on CAPA resolutions
- 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, identifying deficiencies and opportunities for improvement
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What benefits does Baxter offer from day one?
Baxter offers medical, dental, and vision coverage, 160 hours of paid time off and paid holidays, 401K match, employee stock purchase program, paid parental leave, and tuition reimbursement from day one.
Is this a remote position or does it require on-site work?
This information is not specified in the job description.
What are the key responsibilities and skills needed for this role?
The role requires expertise in sterility assurance, including developing and implementing continuous improvement initiatives, ensuring regulatory conformance, providing microbiological expertise for SOPs, change control, and validations, and designing training programs for cleanroom behavior.
What is the company culture like at Baxter?
Baxter emphasizes a mission to save and sustain lives, prioritizes quality over quantity with patients first, fosters creativity and trust within the Quality team, and creates a place where employees are happy, successful, and inspire each other.
What makes a strong candidate for this Senior Manager role?
A strong candidate will have deep expertise as a Sterility Assurance SME, experience with regulatory audits, microbiological knowledge for SOPs, validations, and contamination control strategies, and the ability to drive continuous improvement and training programs.
Baxter International
Provides essential medical products and services
About Baxter International
Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.
Deerfield, IllinoisHeadquarters
1931Year Founded
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Benefits
Health Insurance
Dental Insurance
Life Insurance
Disability Insurance
Health Savings Account/Flexible Spending Account
Unlimited Paid Time Off
Paid Vacation
Paid Parental Leave
401(k) Retirement Plan
401(k) Company Match
Employee Stock Purchase Plan
Commuter Benefits
Mental Health Support
Risks
Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.
Shift to home healthcare may require Baxter to adapt its product offerings.
Growing digital health importance necessitates further investment from Baxter to stay competitive.
Differentiation
Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.
Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.
Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.
Upsides
Baxter's investment in Medically Home aligns with the growing home healthcare market.
Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.
Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.
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