Gowning Room Coordinator Job at Fagron (Wichita)

Gowning Room Coordinator

This role is responsible for maintaining the cleanliness, organization, and inve...

Location

United States , Wichita

Salary:

Not provided

Fagron

Expiration Date

Until further notice

Requirements

Prior experience in cleanroom, pharmaceutical, or GMP-regulated environment (preferred)
Prior experience safely handling and using different disinfectants
Written Communication Skills
Ability to stand for extended periods and perform repetitive cleaning tasks
Problem Solving
Oral Communication Skills (English)
Ability to lift up to 50 pounds
anything over 50 pounds will require a team lift
Strong attention to detail and ability to follow strict SOPs and documentation practices
High School Diploma or Equivalent

Job Responsibility

Perform Daily, Weekly, and Monthly sanitation tasks per schedule in controlled cleanroom environments and communicate effectively via Microsoft Teams to ensure full cleaning coverage across all areas
Assist with remediation cleanings as required
Safely handle, prepare, and apply various disinfectants in compliance with SOPs and safety data sheet (SDS) requirements
Efficiently maintaining gowning supplies (gowns, gloves, shoe covers, hair covers, face masks, etc,), ensuring they are readily available for use while following FIFO (first in, first out) method
Perform area monitoring to ensure all cleanrooms remain free of debris
remove trash and waste promptly
Accurately document all sanitation activities in a timely, GDP- and cGMP-compliant manner
Successfully complete garbing qualifications and maintain certification biannually
Ability to work within controlled environments and always maintaining aseptic techniques
Disinfect all cleanroom surfaces (e.g., counters, shelves, CWFs) by established cleaning methodologies

What we offer

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Fulltime

New

Senior Manufacturing Associate

This position supports contamination control, inspection readiness and process s...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
Technical knowledge of biopharmaceutical upstream, downstream processing, cleanroom operations and single use systems
Experience in writing and owning major/minor deviations, CAPA and change controls related to contamination control and/or manufacturing
Experience leading/supporting investigations, CAPA, audit readiness activities and risk assessments
Basic understanding of GMP and regulatory expectations related to manufacturing documentation, change control, deviations/investigations and CAPA
Working knowledge of contamination control expectations for biologics manufacturing, including cleanroom behaviour, gowning, EM and contamination response
Ability to analyse routine EM/process data, identify trends, communicate risks and escalate appropriately
Strong technical writing, communication skills and ability to work effectively with cross-functional stakeholders and network partners
Ability to work with limited supervision, prioritize assigned deliverables and follow through on commitments
Practical experience and interest in exploring the use of digital technologies (Power BI, Customized ChatGPT etc) to improve workflows and drive continuous improvement

Job Responsibility

Support execution of the ASM1 Manufacturing contamination control program under direction of the Contamination Control Lead
Own deviations (minor/major), perform data gathering/investigation, impact assessment and documentation support for contamination-related events, deviations and CAPA
Lead low-to-moderate complexity investigation workstreams and support complex investigations led by the Contamination Control Lead
Prepare and maintain assigned dashboards, metrics and follow-up trackers for site and network discussions
Support maintenance of cleanroom procedures, gowning practices, contamination response procedures and environmental monitoring program deliverables
Coordinate with the EM Sampling team, area owners and cross-functional stakeholders to ensure sampling readiness, timely follow-up and closure of observations
Drive assigned actions and small-to-moderate improvement initiatives to improve contamination control effectiveness
Support CAPA applicability assessment and implementation of identified CAPA (if required)
Prepare, verify and organize inspection support materials, storyboards, pressure test packages and evidence binders as assigned
Support triage room activities during regulatory inspections, including request coordination, document retrieval and response preparation under lead direction

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

New

Senior Manufacturing Associate

This position supports contamination control, inspection readiness and process s...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
Technical knowledge of biopharmaceutical upstream, downstream processing, cleanroom operations and single use systems
Experience in writing and owning major/minor deviations, CAPA and change controls related to contamination control and/or manufacturing
Experience leading/supporting investigations, CAPA, audit readiness activities and risk assessments
Basic understanding of GMP and regulatory expectations related to manufacturing documentation, change control, deviations/investigations and CAPA
Working knowledge of contamination control expectations for biologics manufacturing, including cleanroom behaviour, gowning, EM and contamination response
Ability to analyse routine EM/process data, identify trends, communicate risks and escalate appropriately
Strong technical writing, communication skills and ability to work effectively with cross-functional stakeholders and network partners
Ability to work with limited supervision, prioritize assigned deliverables and follow through on commitments
Practical experience and interest in exploring the use of digital technologies (Power BI, Customized ChatGPT etc) to improve workflows and drive continuous improvement

Job Responsibility

Support execution of the ASM1 Manufacturing contamination control program under direction of the Contamination Control Lead
Own deviations (minor/major), perform data gathering/investigation, impact assessment and documentation support for contamination-related events, deviations and CAPA
Lead low-to-moderate complexity investigation workstreams and support complex investigations led by the Contamination Control Lead
Prepare and maintain assigned dashboards, metrics and follow-up trackers for site and network discussions
Support maintenance of cleanroom procedures, gowning practices, contamination response procedures and environmental monitoring program deliverables
Coordinate with the EM Sampling team, area owners and cross-functional stakeholders to ensure sampling readiness, timely follow-up and closure of observations
Drive assigned actions and small-to-moderate improvement initiatives to improve contamination control effectiveness
Support CAPA applicability assessment and implementation of identified CAPA (if required)
Prepare, verify and organize inspection support materials, storyboards, pressure test packages and evidence binders as assigned
Support triage room activities during regulatory inspections, including request coordination, document retrieval and response preparation under lead direction

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Gi tech i

Assists with patient care activities and related services under the supervision/...

Location

United States , Aurora

Salary:

20.80 - 31.20 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High School Graduate
Typically requires 1 year of experience in a nursing assistant, medical assistant or similar patient care position
GI Technical Specialist (GTS) certification issued by SGNA by completing the SGNA Associates Program needs to be obtained within 6 months
Basic Life Support (BLS) for Healthcare Providers certification issued by the American Heart Association (AHA) needs to be obtained within 6 months unless department leader has determined it is not required
Ability to work independently and effectively in a fast-paced environment
Basic computer skills
Excellent communication and customer service skills
Excellent organizational skills
Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist frequently during work shift
Must be able to lift up to 50 lbs. from floor to waist

Job Responsibility

Assists with patient care activities and related services under the supervision/delegation of the registered nurse and/or physician including but not limited to intraprocedural support
Assists physicians with accurate retrieval of specimens, specimen preservation, labeling and transportation of specimens to lab
Assists in initiating and/or collaborating with the team for all safety initiatives such as timeout process, traceability of equipment used, and reporting of safety events
Organizes and prepares procedure rooms and equipment according to each physician's specification, checking and assembling proper instruments and equipment needed
Performs high level disinfection and reprocessing of equipment/scopes in a safe and effective manner based on established standards
Cleans, calibrates, operates and performs preventative maintenance on equipment according to manufacturer's recommendations and infection control policies and guidelines
Reports and documents equipment repairs
Documents procedures, images, videos and patient charges utilizing the endoscope and ultrasound information systems
Assists in maintaining inventory for unit by informing unit when supplies are needed, stocking supplies, and receiving ordered supplies
Performs various clerical duties which includes answering of phones, filing, data entry, scheduling and compilation of patient records

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance

Fulltime

Gi Tech I

Location

United States , Aurora

Salary:

Not provided

Advocate Aurora Health

Expiration Date

Until further notice

Requirements

GI Technical Specialist (GTS) certification issued by SGNA by completing the SGNA Associates Program needs to be obtained within 6 months
Basic Life Support (BLS) for Healthcare Providers certification issued by the American Heart Association (AHA) needs to be obtained within 6 months unless department leader has determined it is not required
High School Graduate
Typically requires 1 year of experience in a nursing assistant, medical assistant or similar patient care position
Ability to work independently and effectively in a fast-paced environment
Basic computer skills
Excellent communication and customer service skills
Excellent organizational skills
Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist frequently during work shift
Must be able to: lift up to 50 lbs. from floor to waist

Job Responsibility

Assists with patient care activities and related services under the supervision/delegation of the registered nurse and/or physician including but not limited to intraprocedural support
Assists physicians with accurate retrieval of specimens, specimen preservation, labeling and transportation of specimens to lab
Assists in initiating and/or collaborating with the team for all safety initiatives such as timeout process, traceability of equipment used, and reporting of safety events
Organizes and prepares procedure rooms and equipment according to each physician's specification, checking and assembling proper instruments and equipment needed
Performs high level disinfection and reprocessing of equipment/scopes in a safe and effective manner based on established standards
Cleans, calibrates, operates and performs preventative maintenance on equipment according to manufacturer's recommendations and infection control policies and guidelines
Reports and documents equipment repairs
Documents procedures, images, videos and patient charges utilizing the endoscope and ultrasound information systems
Assists in maintaining inventory for unit by informing unit when supplies are needed, stocking supplies, and receiving ordered supplies
Performs various clerical duties which includes answering of phones, filing, data entry, scheduling and compilation of patient records

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Electrode Manufacturing Technician I

The Electrode Manufacturing Technician I plays a key role in the hands-on fabric...

Location

United States , Salt Lake City

Salary:

Not provided

Blackrock Neurotech

Expiration Date

Until further notice

Requirements

Minimum high school diploma and/or AA or equivalent
0-1 years experience in electronics and/or medical device manufacturing environment, preferably in clean room setting working with small parts
GMP training or experience
Thorough and detail oriented
Excellent reading, writing and communication skills in the English language
Able to work independently with little supervision
Able to handle stressful situations
Excellent interpersonal skills
Must be proficient in computer skills with 2 years’ experience using Microsoft Office
Knowledge of FDA/ISO for medical devices

Job Responsibility

Build acute and chronic microelectrode array implant assemblies in a controlled cleanroom environment
Perform detailed assembly work under a microscope, handling very small components with care
Complete tasks such as wire bonding, micro-soldering, adhesive application, and precise component placement
Follow step-by-step work instructions, procedures, and engineering drawings
Inspect work during the build process and perform basic functional checks to ensure quality
Accurately document production work in accordance with GMP and ISO/FDA requirements
Identify defects or process issues and escalate or support basic troubleshooting
Follow cleanroom protocols, including gowning and contamination control
Support material preparation, inventory handling, and production setup
Work closely with Manufacturing Engineering and Quality teams to support ongoing improvements

Fulltime

Radiology Department Aide

Location

United States

Salary:

18.85 - 28.30 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Completion of a medical terminology class or attendance within six months
High School graduate or equivalent
6 months - 1 year experience
Strong communication skills
Strong customer service skills
Good organization skills
Basic phone skills
Computer skills
CPR certification within 6 months

Job Responsibility

Demonstrate ability to function as part of a Radiology Department Aide pool serving all Imaging modalities
Demonstrate flexibility in starting times to meet demands, inclusive of all shifts and weekend hours
Ability to rotate through and demonstrate proficiency of responsibilities for all imaging modalities
Ability to respond to work and/or change assignments at short notice
Act as a customer service excellence and information team resource person to Radiology patients, associates and partners
Answers questions, solves problems for patients and guests independently or with the assistance of the coordinator, supervisor or manager
Alerts Radiology areas of patient arrivals and transport patients to the appropriate areas as needed
Regular rounding with patient and family to keep informed of status of their exam
Keep complete and detailed rounding logs for each patient seen in Radiology areas
Ensure that inpatient and outpatient waiting areas are kept neat, orderly and fully stocked of supplies, gowns and linens

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Parttime

Radiology Department Aide

Location

United States

Salary:

18.85 - 28.30 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Completion of a medical terminology class or attendance within six months
High School graduate or equivalent
6 months - 1 year experience
Strong communication skills
Strong customer service skills
Good organization skills
Basic phone skills
Computer skills
CPR certification within 6 months
Ability to work holidays, weekends and different shifts

Job Responsibility

Demonstrate ability to function as part of a Radiology Department Aide pool serving all Imaging modalities
Demonstrate flexibility in starting times to meet demands, inclusive of all shifts and weekend hours
Ability to rotate through and demonstrate proficiency of responsibilities for all imaging modalities
Ability to respond to work and/or change assignments at short notice
Act as a customer service excellence and information team resource person to Radiology patients, associates and partners
Answers questions, solves problems for patients and guests independently or with the assistance of the coordinator, supervisor or manager
Alerts Radiology areas of patient arrivals and transport patients to the appropriate areas as needed
Regular rounding with patient and family to keep informed of status of their exam
Keep complete and detailed rounding logs for each patient seen in Radiology areas
Ensure that inpatient and outpatient waiting areas are kept neat, orderly and fully stocked of supplies, gowns and linens

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Parttime

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Gowning Room Coordinator

Job Description

Job Responsibility

Requirements

What we offer

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