Quality Assurance Specialist - Scientific Global Leader

Come join a global leader and take your career to the next level at Labcorp as a Quality Assurance Specialist on our exceptional R&D team! This position offers a hybrid work model with a minimum of 2 days per week in the office at the Labcorp Genetics – Metropark site in Iselin, NJ.

Labcorp’s work in developing new pharmaceutical solutions and testing services has an incredible impact on the lives of millions of patients worldwide, helping transform great science into great medicines. Be a part of this life-saving work!

Candidates given best consideration will have the following experience:

• 5+ years of related experience within a CAP/CLIA environment, knowledge of New York State regulations, including successfully having completed at least one CAP inspection.

• 2+ years relevant experience in areas of Quality Assurance, Auditing, and/or Validation, in regulated industries - preferably in Pharmaceutical, Biotech, Medical device.

• Experience with ISO 13485 and ISO 15189 requirements.

• Laboratory knowledge within a CRO, clinical or academia environment.

Position Summary

The Quality Assurance Specialist is responsible for supporting the execution and oversight of all Quality Assurance activities pertaining to laboratory operations at Labcorp Genetics in NJ.

Key Responsibilities

• Supports the implementation, maintenance, and monitoring of processes and procedures to ensure departments are compliant 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

Preferred Qualifications:

• Experience in non-conformance events, change control management and risk management

• Experience in having completed at least one CAP inspection

• 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

Pay Range: $95,000 - $120,000 annually (USD)

All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. 

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 Employ