Quality Auditor II

Job Description

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 Salary

Contact Information :

jobs@hematogenix.com ; www.hematogenix.com

Hematogenix 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.