Quality Assurance Specialist 3

The Alaka`ina Foundation Family of Companies (FOC) is looking for a Quality Assurance Specialist 3 to support our government customer in Ft. Detrick, Maryland.
DESCRIPTION OF RESPONSIBILITIES:

• Perform duties in BSL-2, BSL-3 and BSL-4 laboratories.
• Maintain un-escorted access to BSL-3 and at least escorted access to BSL-4.
• Successful enrollment in the Biological Personnel Reliability Program (BPRP).
• Provide oversight in compliance with US FDA Good Laboratory Practices (GLP).
• Perform study audits and inspections, critical phase inspections, raw data audits, report audits, facility and process inspections and validation deliverable audits, taking ownership of the Quality Assurance requirements for all GLP studies.
• Attendance and participation in pre-study coordination with study and support personnel.
• Perform inspections of facilities and processes and gap analyses for compliance with GLP or GCP (IAW ICH E6 (R2) Good Clinical Practices) requirements or other regulatory requirements.
  • FPIs - Up to ten (10) per year for GLP Compliance and up to 5 per year for GCP compliance
• Perform audits and compliance inspections of ISO-regulated laboratories, facilities and processes.
  • Conduct approximately six ISO inspections per year
  • Perform Facility Process Inspections at locations other than USAMRIID. These FPIs will involve CONUS travel, up to one (1) per year
• Perform QA audits of Equipment Validation / Computer System Validation (EV/CSV) deliverables for compliance with SOPs, 21 CFR 58 and 21 CFR 11.
• Maintain and manage EV/CSV audit-associated documentation, attend pertinent meetings and coordinate with stakeholders.
  • Approximately one EV/CSV audit per week; each audit may include from a few pages to hundreds to thousands of pages of documentation.
• Generate and manage audit and inspection reports.
  • Write each audit report using MS Word in correct English, with few spelling, grammatical, or technical errors.
  • Distribute each report no later than ten (10) working days after audit completion, target two (2) days after audit completion.
  • Ascertain the adequacy of responses to QA audit report findings.
  • Perform peer review of audit reports within two working days.
  • Maintain, update and archive supporting documentation.
• Compile disparate logs and schedules to generate the USAMRIID Status Report to Command Suite personnel and Study Directors. Provide input to the bi-weekly report to management.
  • USAMRIID Status Report to Study Directors and Management/Command Suite Personnel is four (4) per year
  • Bi-weekly reports are twenty-six (26) per year
• Perform QA review of SOPs and associated forms and appendices for publication, IAW published instructions, responding to authors within ten (10) days of reviewer assignment.
  • Average twenty (20) SOP reviews per month, minimum of ten (10) per month, max is forty (40) SOP reviews per month
  • Participate in software validation projects IAW requirements, approximately one (1) per year
• Attend meetings, represent QARCO and keep QARCO informed of meeting content, decisions and actions.
• Maintain positive working relationships with researchers, technical staff.
• Lead teams and working groups.
• Participate in department and other meetings as assigned, approximately four (4), one-hour meetings per month
• Write and revise department documents, such as SOPs and work instructions and provide peer reviews.
• Improve procedures, workflow and efficiency and/or increase adherence to FDA GLP requirements, FDA regulatory expectations and industry standards, approximately ten (10) documents per year
• Maintain a current GLP training file, to include summary of training and experience.
• Provide training to personnel on regulatory topics, including training co-workers in QARCO tasks and matters of regulatory interest.
• Attend one to two (1-2) conferences per year to maintain continuing education, knowledge and techniques.
• Apply scientific knowledge and regulatory expertise in executing assignments and assisting other teams.
• Manage, file and archive records, to include audits, master schedule, log records. Records are generated and updated in a continual basis, and periodically presented to management, initialed, dated and filed.
  • QA Log Records that are updated continually: up to ten (10)
  • QA Log Reports to QARCO management: up to twelve (12) generated quarterly
• Work with other Quality Assurance Specialists to assist, support and perform critical phase inspections, data audits, report audits, document reviews/audits, study activities and other tasks and activities to provide support, team coverage and cross training.
• Coordinate and host audits by visiting auditors, working with representatives to schedule tours, fielding questions, supplying resources to assure visiting inspectors get an organized view of the entire enterprise.
• Compile reports and files from visiting auditors, assuring documentation from audits withstand regulatory scrutiny and provide adequate institutional memory.
• Manage the staffing, coordination, response, documentation and filing of ancillary audit/inspection reports, CAPAs, After Action Reviews, Hot Wash meetings, etc.
• Participate in sponsor and regulatory inspections as members of the Audit Facilitation Team, approximately four (4) audit/inspections per year
• Maintain information in an electronic database or other format, to include project information, time spent, dates.
• Generate, update and maintain the GLP Master Schedule IAW 21 CFR 58.35 and USAMRIID SOPs, a federally mandated listing of all GLP studies performed at USAMRIID.
  • The GLP Master Schedule is up to thirty (30) GLP studies ongoing at any one time.
  • The GLP master schedule is reported, printed, signed, reviewed and filed four (4) times per year.
  • Act as the back-up Corrective and Preventative Action (CAPA) Coordinator, managing the CAPA system, providing oversight and communications with stakeholders, approximately seventy-five (75) CAPAs per year.
• Stay informed of FDA-regulated industry standards and regulatory expectations through continuing education and relevant certification.
• Provide expertise and leadership for GLP compliance matters.
• Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

• BS and four to five (4-5) years' experience

OR

• MS and two (2) years' experience

REQUIRED SKILLS AND EXPERIENCE:

• This position requires BPRP certification or the ability to obtain it.
• Quality Control/Quality Review in a GLP environment
• FDA Animal Rule experience
• Ability to read, update, and create SOPs
• Experience with incident investigation
• High functioning in a QA audit as contributor and in preparation

DESIRED SKILLS AND EXPERIENCE:

• Previous DoD experience
• Previous working experience in biomedical research

REQUIRED CITIZENSHIP AND CLEARANCE:

• Must be a U.S. Citizen
• An active Secret Clearance is required

The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.
We are an Equal Opportunity/Affirmative Action Employer. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.
The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kapili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.
For additional information, please visit www.alakainafoundation.com
#LI-JS1
#ClearanceJobs