CrawlJobs Logo

Sterility Assurance Specialist

us.gsk.com Logo

GSK

Location Icon

Location:
United States , Marietta

Category Icon
Category:
IT - Administration

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

As a Sterility Assurance Specialist, you will be Subject Matter Expert (SME) for development, implementation, monitoring and improvement of Sterility Assurance Programs at the Marietta Site location.

Job Responsibility:

  • Responsible for improving sterility assurance program at Marietta and sharing sterility assurance best practices between Marietta and other GSK aseptic manufacturing sites
  • Evaluate manufacturing operational practices and strategies to ensure compliance with regulatory requirements. Lead, develop, implement, influence changes to meet requirements and continuously improve sterility assurance processes
  • Responsible for aseptic process simulations, facility cleaning, material transfer, aseptic behavior, Environmental Monitoring, gowning and contamination control strategy programs. Provide oversight and measure effectiveness of Sterility Assurance programs. Maintain and improve LSOPs (local procedures) for these programs and perform periodic review of local procedures (for example- facility cleaning, aseptic behaviors, material transfer, gowning, EM and aseptic simulations)
  • Responsible for trending, generating Environmental Monitoring trend reports and ensuring that Environmental Monitoring and gowning programs are in control. Responsible for all rationale documents and risk assessments to support the environmental monitoring and gown monitoring programs
  • Provide expert advice when changes to classified environments are proposed to evaluate the benefits or disadvantages of the proposed changes and to assist with investigation of excursions. Provide trending data analysis to assist with the evaluation of the impact of excursions. Ensure that the site monitoring strategy for classified areas complies to procedures and external regulatory expectations
  • Interface directly with domestic and foreign regulatory inspectors regarding microbiological and sterility assurance topics
  • Participate in the investigation and planned remedial actions for out of compliance EM / Sterility Assurance results in order to support the timely resolution of investigations
  • Own and execute quality system (CAPA, Change Control, LSOP revisions, gap analysis)
  • Responsible for training, coaching, and qualification program for aseptic techniques, clean room behaviors, and gowning
  • Provide technical guidance for all questions and issues related to sterility assurance topics and support 3 shifts of operation, as required
  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives

Requirements:

  • Bachelor’s degree in microbiology, biology, pharmacy, or related scientific discipline
  • 5+ years pharmaceutical industry experience
  • GMP/Microbiology/Quality or Aseptic Area role to include direct work with environmental monitoring of aseptic filling operations and sterility assurance systems
  • Technical expert in sterility assurance process, environmental monitoring and gown monitoring programs
  • Knowledge of microbiology, contamination control programs to implement and improve cleaning, gowning, aseptic behaviors, material transfer, aseptic simulations and environmental monitoring programs
  • Experience leading investigations, deviations, or microbiological problem solving
  • Ability to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions

Nice to have:

  • Master’s degree in biology or microbiology, pharmaceutical sciences, or related field
  • Advanced practical knowledge of aseptic process simulations, cleaning, gowning, aseptic behaviors, material transfer and environmental monitoring programs required to influence decision making, regulators and stakeholders
  • Experience supporting regulatory inspections and preparing regulatory responses
  • Knowledge of sterility assurance principles, USP chapters, and cleanroom standards
  • Experience with aseptic process validation and gowning practice oversight
  • Familiarity with electronic quality management systems for investigations and CAPAs
  • Strong technical writing skills to produce clear, audit-ready documentation
  • Ability to work collaboratively and escalate issues when needed
  • Champion change and innovation, drive execution and results, motivate others and foster collaboration at all levels of the site
  • The ability to drive site objectives and results
  • work in a fluid environment
  • drive culture & lead department initiatives
  • Demonstrated interpersonal and leadership skills
  • The ability to function and influence within team-based organization
What we offer:
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes

Additional Information:

Job Posted:
May 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
GSK - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon
PREMIUM
More languages and countries
+ Unlock 31694 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Sterility Assurance Specialist

Materials Processing Specialist

As a community, the University of Rochester is defined by a deep commitment to M...
Location
Location
United States of America , Rochester
Salary
Salary:
21.10 - 28.64 USD / Hour
urmc.rochester.edu Logo
University of Rochester
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • One year of post-secondary education and 1 year of related materials processing experience
  • or an equivalent combination of education and experience
  • Certification as a Registered Central Sterile Processing Distribution Technician preferred
  • Computer experience and knowledge of medical terminology preferred
  • If hired on or after January 1, 2014, candidate must pass a nationally accredited central service exam for central service technicians
  • and hold and maintain one of the following credentials administered by a nationally accredited central service technician credentialing organization within eighteen months of hire: certified registered central service technician credential
  • certified sterile processing and distribution technician credential
  • or a substantially equivalent credential
  • In addition, twelve CEU credits must be obtained annually
  • If hired on or before December 31, 2013, ten CEU credits must be obtained annually
Job Responsibility
Job Responsibility
  • Inspects, assembles, packages and sterilizes surgical instrument pans, procedural trays, technical equipment, and surgical case carts for the OR, Ambulatory Care Facilities, Hospital Units and Research Clinics
  • Operates sterilizers
  • prepares and dispenses sterile items
  • inspects and stocks supplies
  • performs inspection, adjusting, cleaning and general servicing of instruments and equipment supplied by the Materials for Surgical Services department to insure instruments and equipment are operating properly prior to issuing
  • Inspects, assembles, packages and sterilizes surgical instrument pans, procedural trays, technical equipment, and surgical case carts: selects method of packaging and sterilization consulting with Processing Manager as needed, examines surgical instrumentation for cleanliness and proper assembly and function
  • assembles instrument sets ensuring appropriate number and type of instrument per ESI software program protocols
  • handles instruments appropriately to ensure sterilization
  • completes count/supply sheets to document contents of tray
  • follows established procedures to package/wrap trays/instruments to guarantee sterilization
  • Fulltime
Read More
Arrow Right

Invasive Tech II

To provide and coordinate high quality patient care in all areas of the Heart an...
Location
Location
United States , Bismarck
Salary
Salary:
29.03 - 39.92 USD / Hour
americannursingcare.com Logo
American Nursing Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Member of the North Dakota Medical Imaging and Radiation Board of Examiners
  • Must hold a Registered Radiologic Technologist RT(R) credential from the ARRT or a Registered Cardiovascular Invasive Specialist (RCIS) and/or Registered Cardiac Electrophysiology Specialist (RCES) and/or Certified Electrophysiology Specialists (CEPS)
  • Basic Life Support within 480 hours of employment
  • AHA Advanced Cardiac Life support certification is required within 6 months of hire date
  • Working knowledge of skills obtained in a Cath Lab/EP Lab
  • Ability to work independently to perform standard and complex procedures under minimal direction
  • Working knowledge of computer skills
Job Responsibility
Job Responsibility
  • Provide and coordinate high quality patient care in all areas of the Heart and Vascular Center
  • Demonstrates technical and professional knowledge in patient care through job knowledge, equipment management, productivity, critical thinking and leadership
  • Manages routine use and quality control requirements of equipment, by adhering to established radiation safety protocols
  • Assists with patient care by the following: patient education of procedure, safe transfer of patient, adhering to infection control and to HIPPA regulations while meeting Core Measurements and Quality Control thresholds
  • Assists physicians by providing quality imaging, facilitating completion of exams, maintaining supplies and assisting with specialized equipment for diagnostic purposes and urgent/emergent procedures
  • Utilized CPT coding for all procedures, and stays current on the charging CPT coding system
  • Assesses patient relative to requested procedure by collecting pertinent data about the patient and procedure and uses professional judgement to analyze data to select the most appropriate and cost-effective products
  • Sets up, maintains, and monitors the sterile field assuring the highest standards of sterile technique are maintained during the procedure
  • Prepares the patient for the procedure assuring that the highest standards are maintained
  • prepares and administers contrast
What we offer
What we offer
  • Up to $30,000 sign on bonus
  • medical, prescription drug, dental, vision plans, life insurance, paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually), tuition reimbursement, retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings
  • Fulltime
Read More
Arrow Right

Materials Process Specialist, Work Leader

Performs duties as set forth in the basic job description in addition to acting ...
Location
Location
United States of America , Rochester
Salary
Salary:
21.95 - 29.77 USD / Hour
urmc.rochester.edu Logo
University of Rochester
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • One year of post-secondary education and 1 year of related materials processing experience
  • or an equivalent combination of education and experience
  • Certification as a Registered Central Sterile Processing Distribution Technician preferred
  • Computer experience and knowledge of medical terminology preferred
  • If hired on or after January 1, 2014, candidate must pass a nationally accredited central service exam for central service technicians
  • and hold and maintain one of the following credentials administered by a nationally accredited central service technician credentialing organization within eighteen months of hire: certified registered central service technician credential
  • certified sterile processing and distribution technician credential
  • or a substantially equivalent credential
  • In addition, twelve CEU credits must be obtained annually
  • If hired on or before December 31, 2013, ten CEU credits must be obtained annually
Job Responsibility
Job Responsibility
  • Inspects, assembles, packages and sterilizes surgical instrument pans, procedural trays, technical equipment, and surgical case carts for the OR, Ambulatory Care Facilities, Hospital Units and Research Clinics
  • Operates sterilizers
  • prepares and dispenses sterile items
  • inspects and stocks supplies
  • performs inspection, adjusting, cleaning and general servicing of instruments and equipment supplied by the Materials for Surgical Services department to insure instruments and equipment are operating properly prior to issuing
  • Inspects, assembles, packages and sterilizes surgical instrument pans, procedural trays, technical equipment, and surgical case carts
  • Operates steam sterilizers in accordance with established procedures
  • Checks and adjusts medical equipment according to specific procedures to insure instruments and equipment are operating according to specifications prior to issuing
  • Decontaminates surgical instruments and equipment following established procedures
  • Receives and stores supplies from outside vendors and Hospital areas
  • Fulltime
Read More
Arrow Right

Invasive Technologist Regional Float

As an Invasive Technologist, you will prepare patients and assist physicians dur...
Location
Location
United States , Council Bluffs
Salary
Salary:
30.76 - 45.76 USD / Hour
americannursingcare.com Logo
American Nursing Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Registered Cardiovascular Invasive Specialist, within 6 - months
  • Basic Life Support - CPR, upon hire
  • Advanced Cardiac Life Support, within 6 - months
Job Responsibility
Job Responsibility
  • Assists with pre-procedure education and preparing patient for procedure
  • Collaborates with other staff to assure patient has a thorough understanding of procedure and is able to answer questions as needed
  • Assures patient is positioned properly for the procedure
  • Assures EKG electrodes are properly placed and cardiac electrodes correctly applied
  • Assures skin is prepped and sterilized appropriately prior to procedural draping
  • Sets up patient and sterile equipment in accordance to the performing physician’s preferences
  • Scrubs and assists physicians during procedures
  • Assists physician in sterile placement of invasive and hemodynamic monitoring equipment
  • Uses fine motor skills to assist physician with the placement/deployment/use of invasive catheters, wires, balloons, stents, structural heart devices, Intra-aortic balloon counter-pulsation equipment, percutaneous left ventricular assist devices, implantable cardiac devices, and electrophysiology catheters/3-D intra-cardiac conduction mapping
  • Performs monitoring function throughout procedures. Documents clinical information in patient record
What we offer
What we offer
  • Up to 20,000 sign-on bonus
  • $10,000 educational assistance
  • medical, prescription drug, dental, vision plans
  • life insurance
  • paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
  • tuition reimbursement
  • retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings
  • Fulltime
Read More
Arrow Right

Manufacturing Specialist Sterile Fill

Perform operations in a line team environment to provide high quality pharmaceut...
Location
Location
United States , Shawnee, Kansas
Salary
Salary:
Not provided
argentaglobal.com Logo
Argenta
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma or GED
  • 2 years manufacturing experience
  • Previous experience using automated inventory systems
  • Previous experience using motorized & non-motorized material handling equipment
  • Demonstrated ability to successfully changeover/set up multiple pieces of packaging/manufacturing equipment and strong troubleshooting skills
  • Good written and verbal communication skills in English
  • Good PC Skills, including use of e-mail, attaching documents to e-mail
  • Previous experience using electronic databases and on-line tools
  • Demonstrate ability to work safely in a production environment
  • Ability to read/interpret/follow instructions regarding workplace documentation
Job Responsibility
Job Responsibility
  • Comply with all workplace standards and safety procedures, including Lockout Tagout, Current Good Manufacturing Practices (cGMPs), Occupational Safety and Health Administration requirements (OSHA), Standard Operating Procedures (SOPs), and Company Guidelines
  • Perform equipment setup and changeover activities
  • Act to safely reduce equipment setup and changeover times
  • Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications
  • Meet line Operational Asset Effectiveness requirements per area targets
  • Escalate downtime properly
  • Perform the daily setup and routine operation of the packaging line, including but not limited to bottle in-feed, unscrambler, filler, bottle capper, torquer, labeler, vision systems, weighing systems, bar coding systems, sealers, disassembly/assembly, cleaning, resolving equipment stoppages and jams, and all material handling as trained
  • Perform preventive maintenance tasks as needed and trained
  • Troubleshoot Variable Frequency Drives and Servo Drive systems as trained
  • Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions
  • Fulltime
Read More
Arrow Right

Environmental Services Training Manager

Aramark Healthcare+ is seeking an Environmental Services Training Manager-3rd sh...
Location
Location
United States , Fort Lauderdale
Salary
Salary:
Not provided
aramark.com Logo
Aramark
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Requires at least 3 years of experience in healthcare environmental services
  • Requires at least 2 years of experience in a management or supervisory role preferred
  • Requires a Bachelor Degree or equivalent experience
  • Model key leadership behaviors and ensure the highest levels of safety, quality and service excellence for employees, clients and consumers
Job Responsibility
Job Responsibility
  • Supervise and coordinate overnight environmental services staff
  • Ensure all assigned cleaning tasks are completed according to department standards and schedules
  • Conduct routine inspections of patient areas, public spaces, offices, and restrooms to ensure cleanliness and sanitation standards are met
  • Monitor and maintain proper use of cleaning equipment and supplies
  • Ensure training supports compliance, operational efficiency, and talent development
  • Create annual training plans, calendars
  • Must be willing to work varies shifts
  • Recruit, train, and supervise trainers or learning specialists
  • Set performance goals and conduct evaluations for training staff
  • Provide coaching, feedback, and professional development opportunities
What we offer
What we offer
  • $2,500.00 SIGN-ON BONUS
  • Fulltime
Read More
Arrow Right

Microbiologist

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
Canada , Alliston
Salary
Salary:
72080.00 - 108120.00 CAD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • College diploma or University Degree in a related field (Microbiology)
  • Experience in a manufacturing environment
  • Proficiency in Word & Excel
  • Previous experience working in a Quality function
  • Knowledge of Aseptic Technique and Microbiological Methods
  • 0- 2 years
  • Strong analytical and problem solving skills and critical thinking abilities
  • Strong communication skills, ability to work with all levels of the organization
  • Strong ability to balance multiple priorities with excellent time management skills
  • Detail oriented with the ability to work under pressure
Job Responsibility
Job Responsibility
  • Perform daily solution bioburden, subvisible particulate matter and endotoxin testing
  • Collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program
  • Sample and test the critical systems like compressed air and water
  • Process the biological indicators associated with sterilizer qualifications
  • Provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc
  • Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis as part of the Environmental-monitoring program
  • Conduct the required testing, incubation and plate reading of these samples in accordance with specifications
  • Perform daily solution bioburden testing for total count and spore count in accordance with approved procedures
  • Conduct testing of raw materials as required
  • Perform processing of biological indicators to support sterilizer qualifications
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Fulltime
Read More
Arrow Right

Certified Sterile Processing Technician

Receives, cleans, sterilizes and stores surgical instruments and equipment.
Location
Location
United States , Miramar
Salary
Salary:
Not provided
mhs.net Logo
Memorial Healthcare System
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma or Equivalent (Required)
  • Certified Sterile Processing and Distribution Technician (CSPDT) - Certification Board for Sterile Processing and Distribution (CBSPD)
  • One (1) year of related experience required
  • Must be certified as CPSDT or any other Healthcare Sterile Processing Association (HSPA, formerly IAHCSMM) certifications listed: Certified Sterile Processing and Distribution Manager (CSPDM), Certified Sterile Processing & Distribution Technician (CSPDT), Certified in Sterile Processing Management (CSPM), Certified Registered Central Service Technician (CRCST), Certified Healthcare Leader (CHL), Certified Surgical Technologist (CST), Certified Instrument Specialist (CIS), Certified Endoscope Preprocessor (CER), or Certified Central Service Vendor Partner (CCSVP)
Job Responsibility
Job Responsibility
  • Receives, cleans, sterilizes and stores surgical instruments and equipment
  • Performs and documents required quality assurance testing and inspections
  • Properly disposes of bio-hazardous substances, chemicals, medical waste, and supplies
  • Cleans, disinfects, decontaminates, and sterilizes surgical instruments and equipment using appropriate methods and substances
What we offer
What we offer
  • $2,500 Sign on Bonus
  • Fulltime
Read More
Arrow Right