Quality Auditor
Company: Hematogenix
Location: Tinley Park
Posted on: July 29, 2022
Job Description:
About Hematogenix Want a job with greater meaning and higher
purpose? Every day Hematogenix employees are warriors fighting a
noble and global war on cancer. Helping patients every day, and
helping partners every day - with our diagnostic and research
services. Hematogenix is looking for talented and highly motivated
individuals to join our team. We offer a competitive benefit
package and career development opportunities to help you achieve
your highest professional and personal goals. We are eager to show
you all we have to offer and how you can grow with us.Hematogenix
is a specialized contract research organization and clinical
laboratory with a global presence. Our team of board-certified
clinical, anatomic and research pathologists work in conjunction
with top scientists from around the world to provide quality
testing, consultation, and guidance for all aspects of the
company's pharma and diagnostic services. Job Summary: A key member
of the Quality Team involved in the auditing of various laboratory
department documents and systems to ensure accurate delivery of
patient results and quality control processes are followed.Primary
Duties and Responsibilities:
- Develop audit plans, conduct quality audits, prepare audit
reports and communicate findings, including compliance risk.
- Support every aspect of internal audit quality system program
from audit planning, implementation, feedback and re-audit as
required.
- Assist in the maintenance of the annual internal and external
audit schedules as requested by management.
- Training employees on quality standards and procedures.
- Ensuring that documents are following GDP.
- Documenting findings and recommendations for improvement.
- Review and evaluate internal audit responses against current
industry standards, regulations and guidelines to assure
compliance.
- Drive closure of corrective and preventative actions to ensure
implementation, compliance and continuing efficacy.
- Actively support regulatory inspections as preparation
coordinator. Respond to, coordinate and fill requests, organize
SMEs in support of regulatory inspections.
- Preparing and presenting quality audit reports to senior
management.
- Keeping abreast of industry standards and regulations.
- Must display in-depth understanding of FDA trends, FDA and EU
regulation. Must be able to demonstrate advanced ability to
evaluate and apply compliance requirements and guidelines to
applicable situations.
- Open to a flexible and fluid work environment. Work on any
assignment as directed.Experience and Education:
- Bachelor's degree in a chemical, physical, biological or
clinical laboratory science, from an accredited institution.
- Must have at least 2 years of experience in pharmaceutical
quality audits including both external and internal auditing.
- Working experience with laboratory information systems.
- Certification as a CQA Auditor preferred.
- Proficient in 21 CFR Part 11
- Exceptional attention to detail.
- Excellent leadership and communication skills.
- Advanced organizational skills.
- Personal computer skills (e.g., Microsoft Word, Excel, Power
Point, etc).
- Must be able to communicate effectively, both verbally and in
writing, with all levels of personnel.Benefits we Offer:
- Medical
- Dental
- Vison
- Life
- 401k
- PTO
- Competitive SalaryContact Information:
www.hematogenix.comHematogenix provides equal employment
opportunities to all employees and applicants for employment and
prohibits discrimination and harassment of any type without regard
to race, color, religion, age, sex, national origin, disability
status, genetics, protected veteran status, sexual orientation,
gender identity or expression, or any other characteristic
protected by federal, state, or local laws.This policy applies to
all terms and conditions of employment, including recruiting,
hiring, placement, promotion, termination, layoff, recall,
transfer, leaves of absence, compensation, and training.
Keywords: Hematogenix, Tinley Park , Quality Auditor, Accounting, Auditing , Tinley Park, Illinois
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