CrawlJobs Logo

Clinical Laboratory Compliance Specialist

advocatehealth.com Logo

Advocate Health Care

Location Icon

Location:
United States , Winston Salem

Category Icon
Category:
Health and Beauty

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

24.10 - 46.05 USD / Hour
Save Job
Save Icon
Apply Position

Job Description:

Department: 60947 Wake Forest Baptist Medical Center - Lab: Compliance POC Q & S. Position Highlights: Shift Schedule: M-F 8:00am - 5:00pm; Department: Laboratory; Location: Winston Salem campus. How You’ll Impact Patient Care: Your responsibilities may include, but are not limited to: [see responsibilities]. Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more.

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
  • Provides education and training as needed and promotes the CAPA process
  • Promotes, educates and ensures patient safety
  • Promotes and ensures chemical safety for all areas of laboratory by maintaining the Chemical Hygiene Plan
  • Ensures delivery of consistently high-quality professional services by maintaining knowledge and expertise of laboratory testing technology and compliance standards/regulations
  • Maintains exceptional level of customer service
  • Maintains skills for the development of testing personnel

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

Nice to have:

  • ASCP preferred
  • Specialty certification preferred
  • Master's degree (MBA, MHA, Masters in a Chemical, Physical, or Biological Science) preferred
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

Additional Information:

Job Posted:
January 28, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Advocate Health Care - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

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

Briefcase Icon

Similar Jobs for Clinical Laboratory Compliance Specialist

Clinical Lab Specialist

This laboratory-based position will provide input to design, evaluation, executi...
Location
Location
United States , Franklin Lakes
Salary
Salary:
30.00 - 35.00 USD / Hour
gomillenniumsoft.com Logo
MillenniumSoft Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required
  • MT/MLT CLS (ASCP) or equivalent experience in a Research environment
  • 5 years+ experience in the Clinical Laboratory environment
  • Strong working knowledge of clinical laboratory science
  • Excellent verbal and written communications skills
  • Awareness/basic knowledge of GCP/GLP and ISO regulations
  • Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab
  • Experience with human blood specimen collection products
  • Product Trouble shooting as it relates to clinical results
  • Strong computer skills
Job Responsibility
Job Responsibility
  • Provides input to and conducts scientific investigations in areas of considerable scope and complexity
  • Explores, identifies and recommends solution, concepts and principles
  • Adapts methodologies as needed for areas related to the core clinical laboratory
  • Conducts clinical testing, maintains laboratory instrumentation/reagent test systems and inventory to strategically align with the priorities within the lab and business objectives
  • Implements and documents Quality Assurance and Quality Control procedures as they pertain to instrumentation and methodology
  • Conducts instrument verification per CLSI guidelines, assists with updates and preparation of procedures and instrument performance documentation in compliance with GLP and GCP
  • Performs Clinical Software Validations (CSV) and all requirements for new instrument validation/qualification as it relates to best practices for the IQ/OQ/PQ in the clinical lab
  • Keeps current in the field of Clinical Laboratory Science through review of technical literature, participation in continuing education via webinars/symposia and or customer visits
  • Trains new associates (permanent or temporary) on the Laboratory workflow
  • Senses and monitors trends in laboratory practices and utilizes this information to recommend new projects and influence ongoing projects
  • Fulltime
Read More
Arrow Right

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...
Location
Location
United States; Canada , Remote; Alberta
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
  • Good knowledge of drug safety and the drug development process
  • Good knowledge/understanding of medical terminology
  • Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
  • 3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
  • US Board Certification/board eligibility or regional equivalent for Canada
  • Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
  • Completion of at least basic training in clinical medicine (residency, internship etc.)
  • Demonstrated success in technical proficiency and scientific creativity
  • Good presentation and verbal/written communication skills
Job Responsibility
Job Responsibility
  • Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
  • Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
  • Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
  • as applicable) and liaising with the client, as require
  • Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
  • Review appropriateness of medical content in narrative for medical coherence
  • Assessing seriousness, listedness / expectedness of reported events
  • Providing medical inputs to case processing team
  • Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative
What we offer
What we offer
  • Flexible approach to work that meets your personal needs
  • Work from home
  • Benefits vary by country
  • Investment in your professional and personal development
Read More
Arrow Right

Center Quality Specialist

Essential Job Responsibilities and Duties and Qualifications
Location
Location
United States , Fort Pierce
Salary
Salary:
Not provided
assessfirst.com Logo
Assessfirst
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma, GED or equivalent required
  • Associates degree preferred or a minimum of (3) three to (6) six months quality or plasma industry experience required
  • Strong verbal and written communication skills
  • Must have above average problem-solving and decision-making abilities
  • Proficiency with computers
  • Must have explicit attention to detail
  • Must have excellent analytical skills, organization skills, and follow-up
  • Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals
  • Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
  • Use hands to handle or feel objects, tools, or controls
Job Responsibility
Job Responsibility
  • Perform donor record file review
  • Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
  • Review medical reports and communication
  • Perform reviews of equipment incidents
  • Verification and release of sample shipment
  • Responsible for the inspection and release of incoming supplies
  • Initiate deviation reports as needed
  • Perform Weekly employee observations
  • Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures
  • Reviews the documentation of unsuitable test results and the disposition of the associated units
  • Fulltime
Read More
Arrow Right

Quality Assurance Manager - CLIA/CAP Laboratory

10x Genomics is establishing its first CLIA/CAP-certified laboratory to bring cu...
Location
Location
United States , Pleasanton
Salary
Salary:
132800.00 - 179600.00 USD / Year
10xgenomics.com Logo
10x Genomics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or Master’s degree in Life Sciences, Medical Laboratory Science, Quality Management, or related field
  • 10+ years of experience in quality assurance within a regulated clinical laboratory (CLIA/CAP environment)
  • Demonstrated experience building or expanding quality systems in a CLIA lab setting
  • Strong working knowledge of CLIA / CAP quality and documentation requirements
  • Additional knowledge of FDA 21 CFR Part 820 and ISO 13485 strongly preferred
  • Experience preparing for and leading CAP inspections and CLIA audits
  • Excellent written and verbal communication skills, with an ability to collaborate across scientific, operational, and regulatory functions
  • Hands-on, proactive, and adaptable, capable of working effectively in an early-stage, fast-growing diagnostic environment
  • Experience with LIMS, electronic QMS tools, and training management systems is required
Job Responsibility
Job Responsibility
  • Clinical Quality Framework Establishment and Oversight: Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations
  • Collaborate closely with CLIA and assay development teams to develop and manage SOPs and work instructions
  • Partner with the broader Quality/Regulatory team to integrate the CLIA lab’s quality infrastructure into 10x’s enterprise-wide quality management system (QMS)
  • Establish and track key quality metrics for laboratory operations (e.g., deviations, nonconformances, complaint handling, audit findings, proficiency testing)
  • In partnership with CLIA Lab Director, ensure inspection readiness and execute regulatory submissions (CLIA, CAP, and state licensure)
  • Operational Quality Support: Provide day-to-day quality oversight of clinical laboratory operations, including review and approval of validation plans, QC data, and reports
  • Serve as QA reviewer/approver for method validation, verification, and change control documentation for both laboratory methods and assay software components
  • Ensure effective management of reagents, instruments, and workflow changes per CLIA/CAP requirements
  • Support onboarding and verification of LDTs transferred from Diagnostic Assay Development teams
  • Act as quality liaison with external auditors and partners
What we offer
What we offer
  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Generous time off
  • Competitive and comprehensive health benefits package
  • Easy-to-use benefits that promote wellbeing
  • Family friendly policies like parental leave
  • Award-Winning Workplace
  • Fulltime
Read More
Arrow Right

Regional Director

This is a management position responsible for providing strategic oversight and ...
Location
Location
United States
Salary
Salary:
147000.00 - 184000.00 USD / Year
neogenomics.com Logo
NeoGenomics Laboratories
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree required (MBA preferred)
  • Five or more year’s sales management experience in a clinical and/or laboratory market environment preferred
  • Proven leadership skills
  • Strong interpersonal and influencing skills at all levels of the organization
  • Supervisory or management experience, preferably of a sales staff
  • Demonstrated record of achievement in a prior sales position
  • Strong closing skills. Prior attendance at formal sales training courses a plus
  • Proven oral, written, telephone and presentation skills
  • Solid knowledge of clinical and/or laboratory market environment
  • Ability to learn and retain product specific information and utilize to position the features and benefits to customers
Job Responsibility
Job Responsibility
  • Achieves the Region’s revenue and profitability quotas
  • establishes an environment and foundation for future sales growth
  • sells and teaches others how to sell value and solutions to customers
  • Provides quality leadership for internal and external customers in all assigned tasks, while upholding company values at all times
  • Directs the selling activities within the Region, inclusive of resource deployment and customer interactions
  • Prioritizes effectively and in accordance with corporate objectives
  • Leads the Sales Territory Representatives and Specialists, inclusive of managing performance, coaching, mentoring, hiring and career development
  • Responsible for forecasting sales activity and revenue achievement
  • Communicate business value through ROI metrics and cost reduction strategies
  • Develop strategies and tactics to develop new opportunities in conjunction with outbound marketing resources
What we offer
What we offer
  • Career coaches internally
  • Many training opportunities to expand your knowledge base
  • Highly competitive benefits with a variety HMO and PPO options
  • Company 401k match
  • Employee Stock Purchase Program
  • Tuition reimbursement
  • Leadership development
  • Start employees off with 16 days of paid time off plus holidays
  • Wellness courses
  • Highly engaged employee resource groups
  • Fulltime
Read More
Arrow Right

Locum Consultant Haematology

We are seeking a skilled and motivated Locum Consultant Haematologist to join a ...
Location
Location
United Kingdom
Salary
Salary:
100870.00 - 111441.00 GBP / Year
remediumpartners.com Logo
Remedium Partners
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Complete registration and licence to practise with the General Medical Council (GMC)
  • MRCP and MRCPath (or equivalent)
  • Entry on the GMC Specialist Register for Haematology, or within six months of CCT/CESR at the time of interview
  • Demonstrable experience and competence in both clinical and laboratory Haematology
  • Proven ability to provide independent clinical decision-making at Consultant level
  • Strong understanding of clinical governance and patient safety principles
Job Responsibility
Job Responsibility
  • Deliver a high standard of Haematology care, including diagnostic, therapeutic, and consultative services
  • Contribute to inpatient and outpatient management, ensuring continuity and quality of patient care
  • Provide cross-site clinical support, with one day per week at a secondary site
  • Participate in laboratory haematology services and multidisciplinary team meetings
  • Take part in the on-call rota, providing clinical advice on transfusion and blood film reporting
  • Engage in teaching and supervision of undergraduate and postgraduate medical trainees
  • Participate in audit, clinical governance, and quality improvement initiatives
  • Maintain compliance with professional, Trust, and GMC standards
  • Support ongoing research programmes and contribute to service development
Read More
Arrow Right

Clinical Specialist Radiographer

The general Clinical Specialist Radiographer in Radiology will manage the genera...
Location
Location
Ireland
Salary
Salary:
Not provided
hermitageclinic.ie Logo
Blackrock Health Hermitage Clinic
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BSc in Radiography or hold a DCR
  • CORU registered
  • Have a recognised post graduate course or be in pursuit of same
  • Minimum of four years’ experience in general x-ray in an acute hospital setting
  • Minimum 2 years’ experience in intervention/Cath lab
  • Familiar with a computerised patient information system and PACS
  • Thorough understanding of legislation relating to Radiation Safety
  • Understand the requirements of and promote CPD
Job Responsibility
Job Responsibility
  • Manage the general radiographers in the fields of x-ray, fluoroscopy and the Cardiac Catheterisation Laboratory
  • Ensure staff comply with all relevant policies and protocols
  • Ensure procedures and enquiries are carried out in an efficient, friendly and professional manner
  • Undertake all general x-ray procedures and maintain a highly specialist standard of technical skill, efficiency and patient care
  • Continually train, supervise and update the radiographic staff
  • Liaise with radiologists and referring clinicians to initiate and develop new procedures and techniques
  • Be responsible for formulating, assessing and modifying operational policy
  • Establish effective interdepartmental liaison
  • Observe the rules, policies, procedures and standards of the Hermitage Clinic
  • Provide clinical leadership for radiographers and ensure an effective learning environment
What we offer
What we offer
  • An Education Support Programme
  • Development opportunities
  • Opportunities for career progression
  • Access to a Pension Scheme
  • Subsidised Restaurant
  • Free staff car parking
  • Employee Assistance Programme
  • Life Assurance
Read More
Arrow Right

Complaint Handling Management Specialist

Complaint Handling Management Specialist for a Medical Device Company. Primary r...
Location
Location
United States , San Antonio
Salary
Salary:
24.00 - 28.00 USD / Hour
gomillenniumsoft.com Logo
MillenniumSoft Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 1+ years of experience with medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with BD products
  • Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations
  • Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485, and Canadian Regulations
  • Ability to work with customers, system administrators, and clinicians
  • Proven ability to maintain a professional demeanor when handling complex user issues and high-pressure situations
  • Expert level knowledge of the Complaints handling system
  • Proven ability to multi-task and seamlessly move between business unit platforms
  • Ability to take ownership and think independently, with minimal supervision
  • General knowledge of producing metrics and building reports
  • Strong analytical, deductive reasoning and listening skills
Job Responsibility
Job Responsibility
  • Medical Device Product Complaint Handling
  • Medical Device Reporting (FDA)
  • Manage intake and reporting of the product complaint handling process including, receipt of complaints from all sources (including Service Cases and Work Orders) and all in process steps complaint determination, Data entry, Critical Thinking to request additional information (as needed), reportability decisions, MDR filing, and serve as point of contact for customer communication
  • Routing the complaint to appropriate location for further evaluation
  • Entering of the complaint into the complaint handling system
  • Checking for complaint accuracy and content, correct information to process the complaint
  • Provide training to personnel involved in overall complaint process as directed by management
  • Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved
  • Maintains annually competencies through training and documentation of training
  • Contact the customer or vendor for further information or follow up
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy