Compliance Auditor

Summary

Oversee and conduct compliance and quality audits of donor center, warehouse, transportation and lab and other suppliers of services and goods auditing activities inspecting for compliance with regulatory and customer requirements and to Standard Operating Procedures (SOP) and current Good Manufacturing Practices (cGMP)

Primary Responsabilities:

• Assess facility compliance with SOPs, applicable domestic regulatory agencies such as FDA, international regulatory agencies such as EMA, federal and state regulations.

• Assess overall facility performance with regard to general operations, such as but not limited to; organization, employee training and cleanliness.

• Prepare and present electronic report of inspection findings with comments to inspected facility, designated corporate directors, appropriate Operations, Quality and Training managers as well as other appropriate persons as requested.

• Interact with facility management and other members of donor center management to assure understanding of audit findings.

• Provide support, suggestions and ideas about improving problem systems to facility employees.

• Recognize areas of improvement and offer solutions to enhance compliance.

• Analyze and evaluate reports prepared by facilities in response to audits performed. Evaluate for adequacy of corrective actions, completeness of report and close audit when satisfactorily completed.

• Manage multiple tasks with competing demands and deadlines.

• Interface with various levels and groups throughout the organization.

• Assist in development of new or revised procedures based on trends, audit findings, interaction with facilities. Recommend corporate-wide solutions or operational changes as necessary.

• Proficient in Microsoft Office suite with emphasis in Word and Excel. Ability to articulate clearly and deliver oral presentations. Solid writing and reporting skills required.

• Travel required.

• This is a remote position.

Education and Experience:

• Bachelors degree hihgly preferred.Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

• Typically requires 5 years of related experience related to the collection and/or testing of human blood and blood components, preparations, storage and distribution.

• Previous experience should demonstrate expertise in SOP development as well as an understanding of quality control principles and QA audit function

• Expert knowledge in SOPs, cGMPs, FDA, CLIA, IQPP and European regulations.

Occupational Demands:

Travel 50% within the United States and Canada for audits.

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

Req ID: 516260

Type: Regular Full-Time

Job Category: Quality