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

Clinical Laboratory Specialist

We are seeking a Clinical Laboratory Specialist to join a dynamic laboratory tea...

Location

United States , San Marcos

Salary:

30.00 USD / Hour

Connexion Systems & Engineering, Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Immunology, Genetics, Molecular Biology, or related field
Exposure to clinical or research lab environments (internships or up to 12 months preferred)
Knowledge of molecular and immunohematology testing (NAT testing a plus)
Strong attention to detail and organizational skills
Effective communication and teamwork abilities
Proficiency in Microsoft Office tools

Job Responsibility

Perform laboratory testing across high-, moderate-, and low-complexity assays
Analyze, document, and report test results with accuracy
Accession and track samples using a Laboratory Information System (LIS)
Maintain compliance with SOPs, cGMP, and quality standards
Support validation studies, feasibility assessments, and new assay development
Conduct routine quality control and assist with equipment calibration
Investigate and report sample discrepancies or technical issues
Maintain a clean, organized, and compliant lab environment
Document deviations and CAPA activities
Assist with training and competency assessments for team members

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

Clinical Support Specialist

We are looking for a detail-oriented Clinical Support Specialist to support pati...

Location

United States , Palo Alto

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Exceptional attention to detail and accuracy
Strong verbal and written communication skills
Ability to manage multiple tasks in a fast-paced environment
Strong customer service and problem-solving abilities
Ability to work independently while maintaining high quality standards

Job Responsibility

Accurately log and process incoming patient samples and test orders
Enter complex laboratory orders into specialized software systems
Provide support and troubleshooting assistance to physicians and healthcare providers regarding test orders
Compile meeting agendas and assist with administrative coordination
Maintain and organize paper-based filing systems and documentation
Ensure data accuracy, completeness, and compliance with established procedures
Handle sensitive patient and healthcare information with confidentiality and professionalism

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Fulltime

Senior Clinical Research Specialist

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

Location

United States of America , Rochester

Salary:

60431.00 - 84603.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor's degree and 3 years of relevant experience required
Ability to effectively manage complex research protocols/procedures required
Fully adheres to applicable safety and/or infection control standards
Proficiency in medical terminology, the clinical research process, and applicable regulatory guidelines, standards preferred
Proficiency in managing multiple and competing priorities/demands
Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, and OSHA guidelines throughout study implementation
Exceptional interpersonal, organizational, and time management skills
highly collaborative, promotes teamwork
Ability to build collaboration among research team members, laboratory staff, patients, and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients)
Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet

Job Responsibility

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols
Manages the day-to-day operations of multiple studies, carrying out study coordination duties from protocol development and initiation through to study close-out in accordance with regulatory/sponsor guidelines
Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures
Works closely with study team members and other study sites to ensure the safety and adherence of study participants to the study protocol
Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities and personnel
Coordinates enrollment of participants
Oversees and facilitates eligibility screening and study recruitment activities
Plans study timelines and schedules appointments and study visits
Manages and organizes case report forms, source documents, and research records
Enters research data into data collection forms and/or study databases

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

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

Specialist, GxP Compliance & Data Integrity

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Qua...

Location

United States , RTP, North Carolina

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience
or Master’s degree in the same fields with 8+ years of relevant experience
Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred
Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
Experience with supplier management program for computerized system suppliers
Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred
Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance

Job Responsibility

Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance

Fulltime

Senior Medical Scientist in Haematology / Blood Transfusion

TTM Healthcare Solutions are delighted to be recruiting for a Senior Medical Sci...

Location

Ireland , Limerick

Salary:

41715.00 - 68478.00 EUR / Year

TTM Healthcare

Expiration Date

Until further notice

Requirements

Coru Registration
The BSc in Science (Applied Science) Honours degree
Masters level qualification in Haematology is an essential requirement due to this being a specialist role

Job Responsibility

Assist in the organisation and co-ordination of the Haematology / Blood Transfusion service
Assist in the implementation and maintenance of a quality management system in Haematology / Blood Transfusion
Participate in developing the Haematology / Blood Transfusion service to meet the clinical needs of our patients and ensuring that the service is consistent with the mission, vision, values and strategic plan of the Hospital
Participate in training staff as required
Participate in leading and training a team of skilled staff, creating and promoting healthy working relationships
Ensure that policy relating to the Haematology Laboratory record keeping is followed
Participate with the Laboratory Manager in facilitating the training of students from relevant college courses
Actively participate in internal and external quality control and quality assurance
Participation in the out of hours on-call rota is mandatory
To perform tasks and duties in a manner that ensures compliance with relevant regulations so that the requirements of International standard ISO 15189 (current version and incorporating AML-BB Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC), JCI ACCREDITATION STANDARDS for hospitals and relevant Medical Devices Directives 93/42/EC and 98/79/EC are met

Fulltime

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Clinical Laboratory Compliance Specialist

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