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Quality Assurance Auditor

Company: Icon Government and Public Health Solutions
Location: Silver Spring
Posted on: June 14, 2019

Job Description:

ICON Government and Public Health Solutions is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.

PRINCIPAL DUTIES AND RESPONSIBILITIES

General: Quality Auditor provides comprehensive quality support to PBF departments to ensure and enhance compliance with Good Manufacturing Practices (GMPs). This includes support in the development of instructional documents (SOPs, batch production records), review of executed documents (batch records), internal auditing for GMP compliance, mentoring/coaching employees in GMP compliance, participation in investigations, and follow-up to verify that identified corrective/preventive actions have been appropriately implemented. Also assists in the execution of other Quality Assurance department responsibilities.

ESSENTIAL FUNCTIONS:

Reasonable Accommodation Statement:

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.

* Learns and maintains understanding of and training in the use of the PBF quality and documentation systems. Follows existing Standard Operating Procedures (SOPs).

* Follows current Good Manufacturing Procedures (cGMP) guidelines and FDA regulations as they apply to all levels of work.

* Assists departments in the creation of Batch Production Records, departmental procedures and policies, logbooks, etc.

* Performs review of completed batch records to determine compliance with all established, approved written procedures and works with departments to resolve discrepancies; monitors status of batch records until completed; prepares Certificates of Analysis for completed lots.

* Assists departments in the initiation of deviations.

* Assists / conducts investigations.

* Works with departments to enhance compliance and productivity. Coaches and mentors staff to improve GMP understanding and application.

* Inspects labeling prior to use for accuracy, completeness and compliance to approved labeling specification. Performs label reconciliation after use.

* Performs internal audits to determine compliance with established, approved written procedures. Works with the audited department to resolve discrepancies and enhance compliance and productivity.

* Verifies that identified corrective/preventive actions have been implemented.

* Serves as an emergency responder in the event of freezer/refrigerator failure in order to protect inventory at risk.

* Maintains a safe workplace; be aware of and observe appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to the position.

* Provide technical assistance to ICON GPHS Headquarters as needed and participate on proposal writing projects when requested.

* Performs light duties and other related duties as required and assigned.

Candidates for positions under ICON GPHS contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT:

Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.

EqualOpportunityEmployerDescription

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

PayTransparencyPolicyStatement

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor s legal duty to furnish information.

Keywords: Icon Government and Public Health Solutions, Silver Spring , Quality Assurance Auditor, Accounting, Auditing , Silver Spring, Maryland

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