Quality Assurance Auditor
Company: Icon Government and Public Health Solutions
Location: Silver Spring
Posted on: June 14, 2019
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.
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
* 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
* 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
* Verifies that identified corrective/preventive actions have been
* Serves as an emergency responder in the event of
freezer/refrigerator failure in order to protect inventory at
* 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
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
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.
Equal Opportunity Employer/Protected Veterans/Individuals with
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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