Clinical Laboratory Compliance Specialist Job at Advocate Health Care (Winston Salem)

Clinical Lab Specialist

This laboratory-based position will provide input to design, evaluation, executi...

Location

United States , Franklin Lakes

Salary:

30.00 - 35.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

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

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

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Manager, Process Development and Automation

The Manager, Process Development and Automation provides leadership support to t...

Location

United States , Redwood City

Salary:

124000.00 - 200000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Engineering, Technology, Molecular Biology, Clinical Laboratory science, Chemical, biological, Electronics, or related field and 2 years’ experience as outlined in the essential duties
or Associates Degree in a Microbiology field or Engineering Science and 4 years’ experience as outlined in the essential duties in lieu of Bachelor's degree
2+ years in a role with progressively increasing responsibilities such as laboratory management, quality and control, lead technologist, or technical specialist
8+ years’ experience in process development, laboratory automation, service engineering, laboratory setting, or related industry as outlined in the essential duties
Successful track record of leading projects holistically from inception to successful implementation with cross-functional participation in a matrixed environment
Proficient in computer aided design software (SolidWorks) or statistical analysis programs (JMP), Microsoft Office Word, Excel, PowerPoint, and similar software
Working knowledge of regulatory requirements to make sure the laboratory is in compliance with all applicable laws and regulations, including applicable CLIA, CAP, California, New York (CLEP), and other requirements
Experience in the design, development, and implementation of solutions comprised of integrated automated and manual workflows, including software components in a highly regulated environment (ISO 13485 or 21 CFR Part 820, or cGMP using 21 CFR Part 210, 21 CFR Part 211)
Understanding and application of user requirements, system requirements, risk assessments, trace matrices, FMEA, etc. translating into a successful track record in understanding complex end-user applications, collecting and clearly documenting end-user needs, and translating those into clear, concise, and testable requirements
1+ years in a leadership role with staff and team accountability

Job Responsibility

Provide leadership on best practices for the development of processes and products in a regulated environment
Lead the team in continuous improvement projects and support other areas’ needs dependent on demand
Coach, mentor, and raise the team's ability to deliver and exceed expectations while creating opportunities for team member development
Consistent demonstration of exceptional leadership qualities
Effectively manage, support, and guide your team
Serve as a resource for employees by sharing and knowledge transfer of best practices for experiment design and execution
Ensure that any incoming support requests from outside of the normal channels are properly routed
Ensure that assigned support requests from cross-functional project teams or business units are being actively addressed
Assist and coordinate training methodology and training documentation in conjunction with other leadership
Provide mentoring and technical guidance to PDA engineers and scientists

What we offer

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

Fulltime

Center Quality Specialist

Essential Job Responsibilities and Duties and Qualifications

Location

United States , Fort Pierce

Salary:

Not provided

Assessfirst

Expiration Date

Until further notice

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

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

Clinical Laboratory QA Specialist

The Clinical Laboratory QA Specialist is responsible for many quality aspects in...

Location

United States , Madison

Salary:

74000.00 - 122000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific major or related field and 2+ years of experience in quality assurance (or quality management system) in a regulated environment
or high school degree/general education diploma and 4+ years of relevant experience with at least 2 years in quality assurance (or quality management system) in a regulated environment in lieu of Bachelor’s degree
Demonstrated ability to collaborate across functions and with both internal and external stakeholders, and to communicate ideas and opinions in a proactive and professional manner
Demonstrated understanding of specific state regulatory requirements for clinical laboratory operations, such as California, New York, Maryland, or Florida
Demonstrated understanding of FDA, CLIA, CAP, HIPAA, or other regulatory body
Proficient in Microsoft Office programs
Demonstrated aptitude for learning new software
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis.

Job Responsibility

Support the monitoring and maintenance of policies and procedures to ensure the clinical laboratory meets respective standards and regulations
Generate laboratory-based metrics to measure efficacy of the quality system and prepare periodic metrics reporting for management oversight
Review and document non-conforming events, conduct investigations, perform root cause analysis, and develop and assist with implementation of corrective and preventive actions
Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback
Review, investigate, evaluate, and maintain patient medical records
Assist in monitoring effectiveness of the quality management system and provide visibility through data and metric reporting
Interact with representatives from the customer care center for follow-up and assist in gathering documentation to support feedback escalations
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Support and comply with the company’s Quality Management System policies and procedures
Maintain regular and reliable attendance

What we offer

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

Fulltime

Microbiology Laboratory Technical Specialist

Microbiology Laboratory Technical Specialist - Full Time - 2nd Shift. Department...

Location

United States , West Allis

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Medical Technologist (MT) or Clinical Laboratory Scientist (MLS) or Histotechnologist (HTL) certification
American Society for Clinical Pathology Board of Certification (ASCP BOC) or equivalent
Bachelor’s Degree in Medical Technology, Clinical Laboratory Sciences, or Histotechnology
Typically requires 2 years of experience as an instrument key operator
In-depth knowledge of moderate and/or high complexity testing as defined by CLIA ‘88
Excellent interpersonal and written/verbal communication skills
Proficient in the use of laboratory computer systems, including use of word processing programs and spreadsheets
Thorough knowledge of statistics and ability to apply statistical rules/analysis to laboratory decision-making processes
Demonstrated ability to work in a fast-paced environment and to successfully handle multiple tasks simultaneously
Demonstrated organizational ability, attention to detail, and accuracy

Job Responsibility

Performs all duties of the bench staff in the specialty as determined by site need (i.e., Medical Technologist, Histotechnologist)
Works with the Supervisor to develop and implement quality control and quality assurance policies and procedures, directly responsible for validation of processes
Ensures that work is completed in a safe and efficient manner
Monitors laboratory safety practices and corrects hazards that exist
Monitors workflow and makes necessary adjustments to complete work in an appropriate time frame
Monitors the preventive maintenance program and regulatory compliance standards to ensure they are met
Participates in the inspection process
Provides financial evaluations as part of procedures, instrumentation, and/or reagent evaluations
If needed, assists the Supervisor with preparation of work schedules, timecards, and attendance functions
Assists supervisor with technical staff development including competency and coaching, correcting performance as needed, coordination and oversight of student and new staff training

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 based on a teammate's job
Incentive pay for select positions

Fulltime

Microbiology Specialist

An exciting opportunity has arisen for a Specialist Doctor in Microbiology to jo...

Location

United Kingdom

Salary:

Not provided

Remedium Partners

Expiration Date

Until further notice

Requirements

Full GMC registration with a licence to practise
Eligibility to work in the UK
MBBS or equivalent medical qualification
FRCPath is Essential
RCPath Part 2 examination completed
Minimum 1 year NHS experience
Experience working within a Clinical Microbiology laboratory at a Speciality Doctor level or equivalent
Significant postgraduate experience in microbiology or a related speciality
Demonstrated clinical judgement, risk management, and decision-making ability
Ability to prioritise workload and recognise when to seek senior input

Job Responsibility

Contribute to the delivery of a comprehensive microbiology service, including bacteriology, virology, mycology and parasitology
Provide clinical advice and interpretation of laboratory results to clinicians across hospital and primary care settings
Attend ward rounds, including Intensive Care Unit rounds, to support management of complex infections
Use clinical knowledge and laboratory data to guide diagnosis, investigation, and treatment decisions
Participate in MDT meetings, incident reviews, and root cause analyses where required
Participate in the 24/7 microbiology on-call rota and achieve autonomous working within 3 months
Act as an active member of the Infection Prevention and Control team
Support outbreak investigation, infection control management, and action planning to reduce healthcare-associated infections
Liaise with infection control teams regarding alert organisms and emerging risks
Contribute to daily laboratory operations and ensure compliance with UKAS standards

Med Technologist Specialist

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

36.87 - 47.93 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree in medical technology and 4 years of relevant clinical laboratory experience required
Licensed Clinical Lab Technologist per New York State upon hire required

Job Responsibility

Provides higher level support for the laboratory section, often involving specialized testing, Quality Assurance development, and/or development and implementation of new procedures
Performs testing and complex interpretation of results
Keeps meticulous notes in regard to experimental methods, data, and conclusions
Develops and maintains applicable standard operating procedures and policies in collaboration with laboratory area leadership
Communicates with internal and external clients clearly and professionally
Assists and leads in the development of new methods and procedures
Performs the duties of a Medical Technologist
Prepares and analyzes patient samples using current complex laboratory methods/instruments
Determines specimen integrity prior to analysis
Reports results of patient sample analysis using computer/instrument interface options

Fulltime

Clinical Laboratory Compliance Specialist

Advocate Health Care

Location:
United States , Winston Salem

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 28, 2026

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Job Description:

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Job Posted:January 28, 2026

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