JOB TITLE: Quality Assurance Specialist/Laboratory Accreditation and Certification Specialist
POSITION NUMBER: 2109-99999-LACS-01 - 2109-99999-LACS-07
POSITION LOCATION: Nationwide (Georgia, West Virginia, Pennsylvania, Ohio, Colorado, Washington, Alaska, Puerto Rico)
ANTICIPATED START DATE: Two weeks after candidate identification
TRAVEL: As required to fulfill the responsibilities of the position
IHRC, Inc. provides scientific, laboratory quality and safety, bioinformatics, and administrative program support to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients. The successful candidate will be a full-time (30-40 hours per week) employee of IHRC, Inc., and will be stationed within a CDC Laboratory Branch to support the establishment of new laboratory quality standards and promote the vertical and horizontal integration of newly-trained quality practices and tools into existing Branch policies and regulatory requirements. Must be able to work onsite at CDC Laboratory branch facilities in Georgia.
SCOPE OF WORK
Under the guidance of the team’s Certified Quality Auditors and LQMS specialists, the Quality Assurance Specialist/Laboratory Accreditation and Certification Specialist will work directly with the Branch Management, Quality Office, Principal Investigators, Laboratory Managers, and other Stakeholders to integrate auditable ISO standard practices into the Branch’s scientific activities. Support the team during mock audits and gap assessments, mentorship and coaching of Branch staff, and assistance with preparation and submission of accreditation application(s).
MAJOR DUTIES AND RESPONSIBILITIES
Support the Quality Office in day-to-day execution of duties. Work with the Quality Office and Branch Management to establish milestone-driven schedule for standing up new quality practices in the Branch to achieve accreditation to at least one ISO standard. Activities may include provision of training, coaching, problem-solving, gap assessment, mock audits, development and/or modification of SOPs and Facility-level policies, program document review and assessment, and reporting.
Education and Experience:
Associate’s Degree in medical technology, health sciences, laboratory sciences, or related field, from an accredited academic institution required. Bachelor’s degree in medical or clinical laboratory science (Medical Laboratory Scientist (MLS), Clinical Laboratory Scientist (CLS), Medical Technologist (MT)) is ideal. College level coursework in biology, chemistry, and mathematics is required.
Past experience working in a standards-regulated laboratory environment is required (e.g., ISO 9001, ISO/IEC 17025, cGMP, GLP).
Must have at least 2-4 years of experience working in a standards-regulated laboratory environment.
Understanding of the effort involved in successful application of standards to the laboratory work environment.
Excellent written and verbal communication skills.
Strong problem-solving skills along with outstanding organizational skills and attention to detail.
Energetic team presence with an eagerness to learn and collaborate with other members of the team.
Must be able to work successfully with limited direct supervision.
Immunizations may be required.
The candidate must possess excellent spoken and written communication skills in English
College level coursework in statistics or biostatistics.
Relevant credential(s). Credential may be from American Society for Quality (e.g., ASQ Quality Auditor, Quality Engineer, Quality Technician), CLSI (e.g., LQMS Certificate), or equivalent.
Relevant professional training. Completion of training programs offered by AIHA, CAP QMEd, or equivalent.
Direct working experience under one or more of the following ISO or ISO/IEC Standards: 17025; 31000; 31010; 13485; 45001; 15189; 20387; 17043; 17034; 15195; 9001.
Must be United States citizen or permanent resident or have authorization for employment in the United States
SALARY: Commensurate with qualifications and experience
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IHRC, INC. IS AN EQUAL OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER. It is the policy of IHRC, Inc. to provide equal employment opportunities without regard to race, color, religion, citizenship, age, sex, sexual orientation, gender identity, national origin, ancestry, genetic information, veteran or disability status, or any other characteristic protected by applicable federal, state or local law, and to take affirmative action in accordance with applicable laws and Executive Orders.
IHRC, Inc. is an international consulting and professional services corporation, and a minority woman-owned small business, founded in 2007 and located in Atlanta, Georgia, USA. We assist our clients in accomplishing their missions and objectives in a timely and cost-effective manner, and we strive to exceed our clients’ expectations.
Science comprises the core of IHRC, and the foundation upon which our broader capabilities are built. Our key executives have extensive experience in science and research, information management, program management, strategic planning, and other areas. Members of our executive management team were integral to the development and implementation of PulseNet, a global laboratory surveillance network dedicated to the rapid recognition of infectious disease outbreaks.
IHRC's largest client is the US Centers for Disease Control and Prevention (CDC). We serve CDC's mission by providing expertise in areas including, but not limited to, bioinformatics, epidemiology, health communications, information management, laboratory science and research, mathematical modeling, and statistics.