What are the responsibilities and job description for the Quality Assurance Specialist position at Labcorp?
Labcorp has a Quality Assurance Specialist role in Iselin, NJ. Join an exceptional team!
Do you have 5 years of related experience within a CAP/CLIA environment? Do you have 2 years relevant experience in areas of Quality Assurance, Auditing, and/or Validation, in regulated industries-preferably in Pharmaceutical, Biotech, Medical device? Apply now!
Knowledge of CAP, CLIA, New York States regulations, including successfully having completed at least one CAP inspection is desirable! Good Candidate prefer experience with ISO 13485 and ISO 15189 requirements!
The Quality Assurance Specialist is responsible for supporting the execution and oversight of all Quality Assurance activities pertaining to laboratory operations at the Labcorp Genetics – Metropark site at 485 F, Route 1, Suite 410, Iselin, NJ.
Duties and Responsibilities:
Supports the implementation, maintenance, and monitoring of processes and procedures to ensure departments are in compliance with relevant guidance and requirements.
Manage the document and record control and archiving activities.
Manage the training and competency program.
Supports the tracking, monitoring, and presentation of operational and quality metrics.
Initiates or supports quality improvements initiatives to enhance performance and/or mitigate quality or compliance risks, as needed.
Supports the implementation of corrective actions as a result of audit observations and investigations, as necessary.
Provides guidance in assessing non-compliance events and supports the team effort to define corrective and preventive actions as well as monitoring their effectiveness.
Supports the audit program.
Supports independent monitoring of study conduct to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with internal procedures and comply with regulations.
Supports the supplier qualification program and may perform audit as needed.
Supports the maintenance of regulated study documentation in accordance with applicable regulations
Minimum Education and Experience Required:
Bachelor’s degree in Life Sciences or equivalent with 5 years of related experience within the healthcare industry (CAP/CLIA environment)
2 years relevant experience in areas of Quality Assurance, Auditing, and/or Validation, in regulated industries-preferably in Pharmaceutical, Biotech, Medical device
Knowledge of CAP, CLIA, New York States regulations, including successfully having completed at least one CAP inspection is desirable
Preferred Qualifications:
Experience in non-conformance events, change control management and risk management
Working knowledge of accreditation standards, practice, and guidelines sufficient to guide laboratory operations
Knowledge of ISO 15189 and ISO 13485 requirements.
Knowledge of GCP/GCLP regulation including knowledge of 21 CFR Part 11
Ability to comprehend regulations and guidance documents and technical information related to equipment, processes, and regulatory expectations.
Strong organizational to communicate to multi-disciplinary project teams.
Familiarity with collecting and reporting Quality Metrics
Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
Capable of working independently with minimal supervision and interacting with staff in a fast-paced sometimes pressure-filled environment
*This position is hybrid, with a minimum of 2 days per week in the office at the Labcorp Genetics – Metropark site in Iselin, NJ.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
