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Manager Aseptic Processing information

What is the difference between Manager Aseptic Processing vs Aseptic Processing Technician?

AspectManager Aseptic ProcessingAseptic Processing Technician
CredentialsBachelor's degree in life sciences or related field, GMP training, leadership experienceHigh school diploma or associate degree, GMP training
Work EnvironmentSupervisory role overseeing aseptic processes in pharmaceutical manufacturingHands-on role operating aseptic equipment in cleanroom settings
ResponsibilitiesManaging teams, ensuring compliance, process optimizationPerforming aseptic procedures, equipment setup, documentation

The Manager Aseptic Processing oversees the aseptic manufacturing process, focusing on team management and compliance, while the Aseptic Processing Technician handles the direct operation of aseptic equipment. Both roles require GMP training and work in sterile environments, but the manager has additional leadership and oversight responsibilities.

What are Manager Aseptic Processing?

A Manager of Aseptic Processing oversees the sterile production environments in pharmaceutical or biotechnology manufacturing. They are responsible for ensuring that products are processed and packaged without contamination, following strict regulatory and safety standards. Their role includes supervising staff, maintaining compliance with Good Manufacturing Practices (GMP), conducting risk assessments, and implementing process improvements. They also play a key part in training employees and managing documentation to ensure product quality and patient safety.

What are some common challenges faced by a Manager in Aseptic Processing, and how can they be addressed?

Managers in Aseptic Processing often face challenges related to ensuring strict compliance with regulatory standards, maintaining a contamination-free environment, and leading cross-functional teams in high-pressure situations. Addressing these challenges requires staying updated on evolving industry guidelines, fostering a culture of continuous training, and implementing robust monitoring systems. Effective communication and collaboration with Quality Assurance, Maintenance, and Production teams are also crucial for swiftly resolving issues and upholding product safety.

What are the key skills and qualifications needed to thrive as a Manager Aseptic Processing, and why are they important?

To thrive as a Manager Aseptic Processing, you need a strong background in microbiology, pharmaceutical manufacturing, quality assurance, and regulatory compliance, often supported by a relevant degree and experience in sterile production environments. Familiarity with Good Manufacturing Practices (GMP), cleanroom management systems, and environmental monitoring tools is essential. Leadership, attention to detail, and effective communication are crucial soft skills for managing teams and ensuring strict adherence to protocols. These skills and qualities are vital to maintain product sterility, meet regulatory standards, and ensure patient safety in pharmaceutical operations.
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Manager Aseptic Processing jobs near you
Sterile Processing Manager - Inpatient Surgery - Maryview Medical Center

Sterile Processing Manager - Inpatient Surgery - Maryview Medical Center

Bon Secours

Portsmouth, VA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 19 days ago

Job description

Thank you for considering a career at Bon Secours!
Scheduled Weekly Hours:
40
Work Shift:
Days/Afternoons (United States of America)
Bon Secours
As a faith-based and patient-focused organization, Bon Secours exists to enhance the health and well-being of all people in mind, body and spirit through exceptional patient care. Success in this goal requires a culture of compassion, collaboration, excellence and respect. Bon Secours seeks people that are committed to our values of compassion, human dignity, integrity, service and stewardship to create an environment where associates want to work and help communities thrive.
Job Summary:
The Manager, Sterile Process will direct the management activities of the Central Sterile department. They will maintain a consistent high standard of providing surgical instrumentation and equipment to all using units. The Manager will serve as a professional role model, mentor and technical instrument and equipment resource and/or educator for Central Sterile Processing and other members of the health care team. They will also maintain in-house turn center processing and or offsite case cart assemble and sterile processing, if applicable. The Manager will act in accordance with sterility per the Association for the Advancement of Medical Instrumentation (AAMI), The Joint Commission (JCAHO), Center for Disease Control (CDC), and state standards of practice.
Essential Functions:
  • Assures that the standards of operation of the department are in compliance with the standards set by regulatory agencies (e.g., State Department of Health, The Joint Commission (JCAHO), DEQ (Department of Environmental Quality), etc.). Facilitates departmental compliance with federal regulatory bodies and exceeds requirements of accrediting organizations.
  • Manages and facilitates functions and staff related to surgical purchasing and sterile processing, if needed.
  • Provides orientation to all new personnel and required training to all staff on a ongoing basis. Ensures that continuous quality improvement in all activities. Develops and implements departmental performance improvement activities.
  • Ensures customer service by meeting legitimate expectations of all customers within the availability of resources.
  • Submits and monitors the departmental budget. Demonstrates a cost -conscious attitude in managing resources and/or activities within the department and organizational budget. Identifies the need for change and process improvements related to cost, quality and service.
  • Communicates pertinent information to staff that may affect daily operations of the department.

This document is not an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. Employees may be required to perform other job-related duties as required by their supervisor, subject to reasonable accommodation.
Education:
  • High School Diploma or GED (required)
  • Associates or Bachelors, Business, Nursing, or relevant field (preferred)

Required Licensing & Certifications:
  • One of the following is required: Certified Registered Central Service Technician (CRCST), Healthcare Sterile Processing Association (HSPA) (required) or Certified Sterile Processing and Distribution Technician (CSPDT), Certification Board for Sterile Processing and Distribution (CBSPD) (required)
  • Certified Instrument Specialist (CIS), Healthcare Sterile Processing Association (HSPA) (preferred)
  • Certified Endoscope Reprocessor (CER), Healthcare Sterile Processing Association (HSPA) (preferred)
  • Certified Healthcare Leader (CHL), HSPA (Required within 1 year of hire)

Experience:
  • 3 years' experience (required) + previous leadership exp (highly preferred)
  • 5 years' experience (preferred)

Skills & Abilities:
  • Ability to Follow Instructions
  • Able to Work Independently
  • Able to work under pressure
  • Anatomy
  • Anticipate Needs
  • Aseptic Techniques
  • Attention to details
  • Business Acumen
  • Communication
  • Communication with multi-levels
  • Computer skills
  • Critical Thinking
  • Decision making
  • Financial Management
  • HIPAA
  • Infection Control
  • Interview skills
  • Knowledge of AAMI Recommendations
  • leadership skills
  • Move with a sense of urgency
  • Performance evaluations
  • Possess Surgical Conscience
  • Preceptor
  • Professionalism
  • Self-Directed
  • Stakeholder Relationship Management
  • Sterile processing workflow
  • Takes Direction
  • Teamwork

Training:
  • EPIC (preferred)

Bon Secours is an equal opportunity employer.
As a Bon Secours associate, you're part of a Mission that matters. We support your well-being - personally and professionally. Our benefits are built to grow with you and meet your unique needs, every step of the way.
What we offer
  • Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)
  • Medical, dental, vision, prescription coverage, HSA/FSA options, life insurances, mental health resources and discounts
  • Paid time off, parental and FMLA leave, short- and long-term disability, backup care for children and elders
  • Tuition assistance, professional development and continuing education support

Benefits may vary based on the market and employment status.
Department:
Inpatient Surgery - Maryview
It is our policy to abide by all Federal and State laws, as well as, the requirements of 41 CFR 60-1.4(a), 60-300.5(a) and 60-741.5(a). Accordingly, all applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you'd like to view a copy of the affirmative action plan or policy statement for Mercy Health- Youngstown, Ohio or Bon Secours - Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employer, please email recruitment@mercy.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at recruitment@mercy.com.
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About Bon Secours

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As a faith-based and patient-focused organization, Bon Secours exists to enhance the health and well-being of all people in mind, body and spirit through exceptional patient care. Success in this goal requires a culture of compassion, collaboration, excellence and respect. Bon Secours seeks people that are committed to our values of compassion, human dignity, integrity, service and stewardship to create an environment where associates want to work and help communities thrive.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Marriottsville, MD, US

Year founded

1983

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