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Internal Auditor
4 months ago
Description
Job purpose
The internal auditor is responsible for executing and maintaining a comprehensive and effective internal auditing program compliant to Standard Operating Procedures in addition to FDA, AATB, ISO 9001:2015, and State regulations and standards. The internal auditor must have strong verbal and written communication skills.
Duties and responsibilities
Internal Audits
Assist in development of internal audit plans and schedules.
Perform recurrent inspection rounds of the different tissue bank departments.
Perform periodic internal audits of all quality systems for compliance with federal, state, and accrediting bodies regulations and standards.
Draft inspection results and audit reports to communicate the outcomes of audits to the corresponding management staff.
Other duties and responsibilities as assigned.
Quality Assurance
Maintain knowledge of, and support, Vivex Biologics, Inc. (Vivex) policies and procedures;
Maintain knowledge of appropriate regulatory, statutory, accreditation requirements, and current Good Tissue Practices;
Support site inspections by the FDA and other agencies;
Responsible for reporting all variances, errors, and deviations on all Vivex initiated documentation according to procedure.
Participate in the investigation, implementation of corrective actions, and documentation of complaint files and nonconformance reports, as needed;
Requirements
Qualifications:
Education:
· Bachelor’s Degree preferred
· A minimum of 2 years of auditing experience in a GMP related environment required.
Experience:
· Strong knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211) preferred;
· Possess working knowledge of technical concepts required for cGTP, or cGMP auditing in the tissue, medical device, biologics, or pharmaceutical industries preferred.
· Experience with electronic document management preferred.
Skills:
· Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment and as a leader.
· Ability to work on multiple assignments in collaboration with other departments with the successful completion of projects;
· Strong organizational skills and attention to detail a must; Excellent writing and editing skills;
· Excellent computer and word processing skills with MS Word;
· Experience with Adobe Acrobat, Visio, Adobe Sign, DocuSign preferred;
· Advanced knowledge of Microsoft Suite (e.g., Excel, Word, Visio, etc.).
Licenses/Certifications:
CTBS or ASQ certification preferred.
Working conditions
Primarily a quiet office work environment. Some evening and weekend work may be required. Facility temperatures are maintained cool.
Physical requirements
While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.
Direct reports
No direct reports.
Nothing in this job description restricts management’s right to assign or reassign duties and
responsibilities to this job any time.
VIVEX is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.
VIVEX complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
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