Quality Assurance Manager

Title: Quality Assurance Manager

Location: On Site, Frederick, MD

Status: Full Time

Travel: Negligible

Salary Range: $85,000-$115,000

Position Summary:

USAMRIID, located at Fort Detrick, Maryland, works closely with other U.S. Army Medical Research and Development Command (USAMRDC) organizations, Department of Defense (DoD), the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health. This includes conducting Research, Development, Testing, & Evaluation (RDTE) of medical countermeasure against biological threats and the safety, quality assurance, project management, and core support required for these research activities.

The Diagnostic Systems Division (DSD) provides reference diagnostic and disease assessment consultation within the medical community in support of DoD operational requirements. DSD supports analytical studies for advanced development and FDA clearance of diagnostic assays as well as pre-clinical studies of vaccine and therapeutic candidates. The division is functionally organized into four departments: Developmental Diagnostics, Applied Diagnostics, Operational Diagnostics, and Regulated Products.

The Quality Assurance Manager will oversee and maintain quality systems related to ISO 17034, ISO 17025, and CLIP functional accreditation for the division. This includes performing audits, managing inspections, and ensuring compliance with quality standards for laboratory processes. The role involves supporting continuous improvement efforts, maintaining equipment qualification and software validation programs, and interacting with external and internal stakeholders to sustain the laboratory's accreditation and high-quality performance. The individual will also be responsible for managing and reporting on the Quality Management System (QMS), conducting audits, and ensuring compliance with industry standards. This position is contingent upon contract award.

Duties/Responsibilities:

• Maintain all documentation necessary for ISO 17034, ISO 17025, and CLIP functional accreditation and ensure the laboratory retains its accreditation on a yearly basis.
• Perform quality systems audits in support of accreditation and GLP studies. Typically, this involves 12 audits per year, covering all aspects of ISO 17034, ISO 17025, and CLIP accreditation.
• Organize and support external inspections and quality systems management inquiries to maintain divisional accreditation. This includes handling 3 inspections or accreditation filings per year and providing monthly reports on the status of quality management inspections.
• Interact with external divisional personnel for all support activities related to the maintenance of the Divisional Quality Management System (QMS), including equipment, facilities, and audits, with regular monthly interactions.
• Develop and implement programs aimed at improving laboratory quality and performance. This includes ensuring the laboratory's retention of accreditation as a reference material producer and clinical diagnostic facility. Reports on quality improvement programs will be provided annually with quarterly updates.
• Oversee and continuously improve the Division's equipment qualification and software validation programs, QMS processes, and procedures, typically conducting one validation per quarter.
• Attend training sessions such as those from Assessment Accreditation Services (A2LA) or other laboratory accreditation programs to supplement existing quality improvement programs. Travel may be required.

Minimum Requirements:

• Bachelor's degree in Quality Management, Biotechnology, Laboratory Science, or a related field.
• 5 years of experience in quality management, with a focus on laboratory accreditation, ISO 17034, ISO 17025, and CLIP standards.
• Proven experience in conducting audits related to quality management systems (QMS), including ISO 17034, ISO 17025, and CLIP.
• Experience with laboratory inspections and accreditation processes, including interacting with external agencies and preparing required documentation.
• Experience in developing and implementing quality improvement programs for laboratories and ensuring compliance with regulatory standards.
• Familiarity with equipment qualification and software validation programs, particularly in laboratory settings.

Work Environment:

• Laboratory environment

Physical Demands:

• May lift up to 25lbs

Benefits:

KIC offers a comprehensive benefits package to eligible full-time employees including: Medical, Dental, and Vision Insurance, 401k with Match, Life and ADD Coverage, Short and Long Term Disability, Paid Time Off and Holidays, Education Assistance/Tuition Reimbursement, Employee Assistance Program, Employee Discount Program, and more!

Apply online at our website: https://kikiktagruk.applicantpool.com/

Disclaimer:

This is not to be an exclusive list of all responsibilities, duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, sex, national origin, religion, age, physical or mental disability, family responsibility, marital status, sexual orientation, political affiliation, veteran's status, gender identity, or any other legal protected status.

Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders, and their Descendants.

Successful candidates must adhere to KIC's Drug and Alcohol policy/testing requirements and may be required to pass a background and/or Motor Vehicle Records check.

The salary range for this position is based on several factors, including relevant experience, education, skills, and current market conditions. We aim to provide a fair and equitable salary, that remains competitive within the industry.