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Head of Technical Writing
2 months ago
The Technical Director II will be responsible for the overall operations and administration of the HLA, Relationship Testing and Consumer Genetics departments within the Burlington DNA Identification Testing Laboratory in order to service clients and patients in accordance with contractual obligations, industry standards, scientific integrity and regulatory requirements. This person will represent the facility on all accreditation/client inspections, audits and partner with other EBU Technical/Laboratory Directors as needed.
*Work Schedule: *Monday - Friday 1st shift
*Benefits:* 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. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. Collaborate with laboratory management on the overall operations and administration of multiple technical departments including staff oversight and development according to defined metrics to ensure uninterrupted operations, scientific integrity of lab activities and validity of test results.
* Working closely with Labcorp’s National Office of Quality, oversee regulatory activities in the laboratory including CAP, ASHI, AABB, ISO, New York State, other and private audits.
* Serve on DNA Identity Management Team/meetings.
* Provide guidance to multiple levels of laboratory staff members regarding standardized procedures related to technical lab operations including quality control and validation decisions.
* Collaborate with the laboratory managers on proposed technical changes requiring LD approval including notification of any proposed receipt of clinical trial samples, or other client testing affecting review and testing of samples.
* Enforces and assures that prompt corrective action is taken in respect to laboratory audit findings or deficiencies noted with regards to implemented quality programs and operational process improvement initiatives.
* Oversees the monitoring of all laboratory activities including writing, reviewing, editing and signing of SOPs, LabFactor and other documentation(s).
* Serves as SME for customer contract/RFP/ITB reviews including assistance with law suits, subpoenas, depositions and other legal related activities in partnership with Labcorp legal department
* Participates in external customer negotiations (give presentations, review marketing materials for technical accuracy) with respect to technical, scientific and/or laboratory request as needed, and provide internal customer support regarding lab technical issues.
* AABB requirements include 2 years of training or experience in relationship testing in an AABB accredited laboratory (or equivalent) or under the guidance of a laboratory director currently or previously employed in an accredited laboratory
* Demonstrated ability to lead and manage a high complexity clinical testing laboratory
* As an EOE/AA employer, Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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.
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