QA Auditor (HOST ROLE), GCP - REMOTE US based opportunity
Company: Labcorp
Location: Burlington
Posted on: March 19, 2023
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Job Description:
Labcorp Drug Development is hiring for QA Compliance Lead
Auditor, with seasoned background in GCP (preferred experience in
GCP hosting) and regulatory policies. This is a remote US based
opportunity ( with preference for candidate located in or near
Durham, NC or Princeton, NJ ).
Ideal candidate is looking to increase leadership, continue to
enhance day-to-day work specific to GCP / hosting, and in
regulatory and must be detail oriented with strong communication
skills.
What to Expect:
Job Responsibilities include but not limited to: Takes lead in
generation of global QA policies on interpretation/ application of
regulations Provide subject matter expertise and leads/influences
the CDS organization by providing guidance and client/authority
facing support on specific niche regulatory topics Hosts (i.e. for
cause inspection, non-standard authority inspections,
country-specific or scope of inspection) external
audits/inspections e.g. regulatory inspections, strategic clients.
Facilitates and reviews responses to the audit. Leads the reporting
of quality metrics and implementation of necessary corrective
actions and/or process improvements via appropriate forum (e.g.
Monthly Reports, Site Quality Review, Liaison meetings). Manage
(for own area of expertise) / participate (for multi-regulatory
topics) in broad scope global Quality initiative(s) aimed at
improving compliance and/or efficiency of the QA organization Acts
as a backup for QA Manager; provides monthly report of activities
to QA Manager; performs other related duties as assigned Ensure
Regulatory Compliance and Quality Assurance (RC&QA)
responsibilities, as indicated in applicable controlled documents,
are followed
Travel Expectations:Travel to LDD facilities (Durham, NC and/or
Princeton, NJ) may be required to host/support onsite client audits
/ regulatory inspections ( 20%); most audits may be hosted
remotely
Qualifications / Experience: 8 years in regulatory environment
(experience in GCP roles) Regulatory expertise - detailed knowledge
of specific regulation/ multiple regulations Experienced Lead Host
Strategic communication with clients Experience leading process
improvement initiatives
Qualifications / Education: A minimum of a Bachelor's Degree in a
Pharmacy, Chemistry or Biology related discipline Postgraduate
degree (MSC or equivalent) in science or management related
discipline, preferable Experience may be substituted for
education.
US Pay Range: $95,000 -$148,000 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), Company bonus where
applicable. For more detailed information, please click here .
As a leading contract research organization (CRO), Labcorp Drug
Development provides comprehensive drug development solutions for a
range of industries. Our services cover the preclinical, clinical
and post-market phases of drug development, the product life cycles
for medical device and diagnostics and development services paired
with regulatory support for the chemical testing and crop
protection industries.
Labcorp Drug Development is a global leader in nonclinical safety
assessment, clinical trial testing and clinical trial management
services. Our unique perspectives are based on decades of
scientific, medical and regulatory expertise.
In July 2022, Labcorp announced its intention to spin off its
clinical development business as a separate public company, subject
to the satisfaction of certain customary conditions. Fortrea will
become the new brand identity for our Clinical Development business
in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right
partner, so we are looking for the right people to help build a
transformative force in Clinical Development.
Labcorp is proud to be an Equal Opportunity Employer:
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.
We encourage all to apply.
For more information about how we collect and store your personal
data, please see our Privacy Statement .
Keywords: Labcorp, Burlington , QA Auditor (HOST ROLE), GCP - REMOTE US based opportunity, Accounting, Auditing , Burlington, North Carolina
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