Clinical Lab QA Coordinator Job at Advocate Aurora Health (Rome)

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Clinical Lab QA Coordinator

Coordinates and reviews quality management records within the Laboratory, overse...

Location

United States , Rome

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Registration as a Medical Laboratory Scientist (MT, MLS, CLT, CLS) by the Board of Registry as ASCP, AMT, AAB (AAB with 15 years experience) or equivalent
If not registered must be registry eligible – All newly hired technical staff must pass an approved certification exam within twelve (12) months of placement in this occupational classification
Must be a High School or GED Diploma graduate
Baccalaureate degree from an accredited college or university to include minimum of 30 quarter hours of lecture science, including at least 15 quarter hours of chemistry, 10 quarter hours of biology, and 5 quarter hours of mathematics (or equivalent semester hours)
4 years of experience in general laboratory
Must have computer knowledge and skills
Must have manual dexterity, must maintain patient confidentiality
Must be able to use visual acuity to see monitor screen, computer and hard copy materials
Must be able to hear and verbally communicate in person and over the phone or radio
Must be able to sit for prolonged periods of time (up to 2 hours)

Job Responsibility

Establishes, directs, maintains, and reviews the Laboratory Quality Assurance Program and participates in the hospital Quality Assurance Program
Assumes responsibility of coordinating Laboratory proficiency testing programs
Guides and assists on quality assurance issues including AABB, CAP, FDA, and DNV inspections
Regularly reviews accrediting agency requirements and guidelines for compliance
At staffing requirements, performs under the laboratory’s Medical Laboratory Scientist major job functions, reporting to the assigned section Technical Leader and performs, maintains, and reviews scheduled quality control for appropriate areas
Participates in appropriate System QA committees, tasks forces, and activities
Maintains supply management for QA budget to include accreditation expenses
Conducts monthly departmental Quality Management meetings pertaining to quality assurance issues
Oversees and coordinates the document control process for laboratory policies and procedures
Oversees and coordinates the incident review process for the laboratory

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

Clinical Lab QA Coordinator

Coordinates and reviews quality management records within the Laboratory, overse...

Location

United States , Rome

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Registration as a Medical Laboratory Scientist (MT, MLS, CLT, CLS) by the Board of Registry as ASCP, AMT, AAB (AAB with 15 years experience) or equivalent
Must be a High School or GED Diploma graduate
Baccalaureate degree from an accredited college or university to include minimum of 30 quarter hours of lecture science, including at least 15 quarter hours of chemistry, 10 quarter hours of biology, and 5 quarter hours of mathematics (or equivalent semester hours)
4 years of experience in general laboratory
Must have computer knowledge and skills
Must have manual dexterity
Must maintain patient confidentiality
Must be able to use visual acuity to see monitor screen, computer and hard copy materials
Must be able to hear and verbally communicate in person and over the phone or radio
Must be able to sit for prolonged periods of time (up to 2 hours)

Job Responsibility

Establishes, directs, maintains, and reviews the Laboratory Quality Assurance Program and participates in the hospital Quality Assurance Program
Assumes responsibility of coordinating Laboratory proficiency testing programs
Guides and assists on quality assurance issues including AABB, CAP, FDA, and DNV inspections
Regularly reviews accrediting agency requirements and guidelines for compliance
At staffing requirements, performs under the laboratory’s Medical Laboratory Scientist major job functions, reporting to the assigned section Technical Leader and performs, maintains, and reviews scheduled quality control for appropriate areas
Participates in appropriate System QA committees, tasks forces, and activities
Maintains supply management for QA budget to include accreditation expenses
Conducts monthly departmental Quality Management meetings pertaining to quality assurance issues
Oversees and coordinates the document control process for laboratory policies and procedures
Oversees and coordinates the incident review process for the laboratory

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

Senior Manager, Clinical Biomarker Operations

The Department of Research and Translational Medicine is seeking a Sr. Manager, ...

Location

United States , Boston

Salary:

160000.00 - 175000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MS or higher with > 3 years or BS with >5 years of direct experience in biomarker operations role
Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection to long-term storage
Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking, and final reconciliation of activities
Experienced in all phases of clinical trials, Phase 3 experience is an asset
Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays, and drug development in general
High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines
Experience in I&I indications
Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines
Successfully exhibits Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel, including a minimum of ~4 times per year for All Hands meetings and other workshops

Job Responsibility

Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition
Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications
Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions
Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance
Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships
Support QA in vendor audit and inspection activities
Support activities related to biomarker budget planning and tracking of accruals
Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards
Continuously identify and build best practices for process improvements
Ensure high quality data generation by overseeing sample integrity and external collaborations

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Vice President, Quality

The Vice President, Quality serves a pivotal role in providing quality leadershi...

Location

United States , Verona

Salary:

280000.00 - 340000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

BS in Life Sciences or related discipline
15+ years in QA or compliance with particular experience in cGMP commercial manufacturing environment and with experience in GCP clinical programs for drugs and/or biologics preferred
10+ years in a previous management role
Experience with developing a QMS and hosting successful regulatory agency inspections
Ability to thrive in a fast-paced environment, with experience in sponsor quality oversight responsibilities for contract vendors across all GxP areas
Implementation of internal phase appropriate GMP drug substance manufacturing & testing systems
Prior successful management of a Quality Management System for commercial product
Drug development through commercial manufacturing compliance experience
Excellent oral and written communication skills required
Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint)

Job Responsibility

Develop and facilitate Quality Systems as delineated in the Quality Manual to support Arrowhead’s clinical development pipeline and preparations for product commercialization
Implement and maintain an overall Quality Management System (QMS) meeting the requirements of activities conducted within Arrowhead
Develop and oversee the internal Quality Control (QC) lab department and operations
Support activities relating to clinical QA GCP regulations at the Pasadena location
Ensure systems are in place for conducting and tracking employee training required by GxP regulations
Support efforts pertaining to internal design, construction, commissioning, and qualification of GMP facilities
Review and approve outsourced contract manufacturing documentation such as validation protocols and reports
master batch records
deviations
analytical methods and methods validation

What we offer

competitive salaries and an excellent benefit package

Fulltime

New

Sr Product Owner

The Product Owner works in a highly dynamic environment, engaging and coordinati...

Location

United States , San Diego

Salary:

112000.00 - 168000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Master’s Degree in Computer Science, Biomedical Engineering, Bioinformatics, or related field
or Bachelor’s Degree in same fields and 3 years of experience in lieu of Master’s
2+ years of experience as a Business Analyst, Project Manager, and Project Coordinator
2+ years of direct work experience as a Product Owner, Product Manager, or Business Analyst in genomics, healthcare, or in a laboratory
3+ years of experience in Agile/Scrum or equivalent software development lifecycle
Demonstrated ability to develop and launch product to successful completion
Demonstrated ability to perform the essential duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Job Responsibility

Understand end-to-end sample to answer workflows
Experience with rules driven workflows, shared biomarker/variant knowledgebases, and multiproduct report generation platforms
Comfort operating under CLIA/CAP/FDA constraints
Own intake, prioritization, release discipline and change control for clinical curation, rules, and reporting capabilities
Coordinate multiple parallel workstreams
Regularly sync with medical, lab operations, quality/regulatory, bioinformatics, IT, and customer experience teams
Surface cross-team conflicts, capacity constraints, and safety/regulatory concerns early
Automation-at-scale thinking
Develop and recommend technical software solutions
Support clinical genomics sample-to-answer workflows

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
Retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

Fulltime

Medical Assistant Certified/Registered- OB/GYN

Cape Fear Valley OB-GYN, located in Fayetteville, North Carolina, is a prominent...

Location

United States , Fayetteville

Salary:

15.50 - 20.25 USD / Hour

OysterLink

Expiration Date

Until further notice

Requirements

high school diploma or equivalent
basic life support (BLS) certification from the American Heart Association
graduation from an accredited Medical Assistant Program with successful completion of a nationally recognized certification exam
1 year clinical experience in an outpatient clinical setting preferred
ability to recognize life-threatening situations and activate emergency services
effective communication skills to interact with patients, staff, and providers in-person and via phone
ability to see, hear, read, and use office and clinical equipment
physical ability to stand, walk, bend, and lift
willingness to follow infection prevention and safety guidelines
adherence to OSHA and CFVH policies for handling biohazard and pharmaceutical waste

Job Responsibility

maintains patients' rights, confidentiality, dignity, and well-being
maintains an accurate, relevant record of patient care and patient contact per visit and per telephone
collects and processes all point of care, lab, and pathology samples per CFVH policy
performs quality and safety checks on all waived testing equipment and supplies per CFVHS policies
performs patient education under the direction of the provider
administers and records treatments, dressing changes, medications, and therapies under the direction and order of the LIP
chaperones, sets up for, and assists providers in procedures and examinations as needed
properly handles and prepares reusable instruments for return to central sterile processing for sterilization
disposes of biohazard and pharmaceutical waste per OSHA guidelines and per CFVH policy
maintains a clean patient care environment by following infection prevention standards for between patient cleaning and terminal cleaning

What we offer

Health Insurance
Dental Insurance
Paid Time Off
Retirement Plan
Sign-On Bonus

Fulltime

Clinical Laboratory Compliance Specialist

Department: 60947 Wake Forest Baptist Medical Center - Lab: Compliance POC Q & S...

Location

United States , Winston Salem

Salary:

24.10 - 46.05 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Bachelor's degree in clinical laboratory science from an accredited institution or a bachelor's degree in a Chemical, Physical, or Biological Science required
Five years' clinical laboratory experience required
ASCP preferred
Specialty certification preferred
Master's degree (MBA, MHA, Masters in a Chemical, Physical, or Biological Science) preferred

Job Responsibility

Assists with the coordination, development, implementation, and evaluation of a compliant laboratory program for all entities of Wake Forest Baptist Health
Develops policies and procedures to address regulatory requirements
Works collaboratively with lab and hospital leadership
Develops and coordinates required training and competency assessments
Provides assistance to areas with CMS-116 CLIA notification forms
Provides consultative support regarding interpretation and implementation of regulatory standards
Monitors all ECRI and Recall alerts pertaining to the laboratory
Monitors Quality Assurance (QA) activities for testing sites
Provides consultative support for Proficiency Testing needs
Prepares for and participates in all applicable accreditation inspections

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
Opportunity for annual increases based on performance
Premium pay such as shift, on call, and more
Incentive pay for select positions

Fulltime

Engineering Technician

Engineering Technician position for a Medical Devices Company in Tempe, AZ. 6+ M...

Location

United States , Tempe

Salary:

18.00 - 22.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

0-3 years of experience
ability to follow instructions, collect data, record results
ability to operate lab equipment
Min High school diploma/GED
associates of science degree in technical discipline preferred

Job Responsibility

Product Builds: Assist, coordinate and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales
Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development
Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and test protocols which comply with GMP and Quality requirements
Test Method Development: Review test methods during test method development and assists with test method validations
Testing: Ability to perform tests by following instructions from development engineers
collect data and record test results
analyzing test data, organizing and presenting when it is necessary in a reportable format
Training: Provides process/test method training to manufacturing and QA personnel
Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule. Ensure equipment is operating properly. Obtaining quotes for testing and calibration
Materials/Inventory: generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking, shipping materials/receiving materials, preparing commercial invoices and liaising with internal Customs specialists

Fulltime

Clinical Lab QA Coordinator

Advocate Aurora Health

Location:
United States , Rome

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 19, 2026

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Job Description:

Job Responsibility:

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