QA Specialist II/III (req2024)

Posted: 7/21/2021
Location: Frederick, MD
Employee Type: exempt full-time
Job ID: req2024

PROGRAM DESCRIPTION

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports Frederick National Laboratory Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

QA Specialist II

  • Reviews batch records and test results for completeness, accuracy and conformance to specifications
  • Reviews and releases raw materials for conformance to specifications
  • Performs in-process audits of manufacturing, analytical, and other activities
  • Performs area clearance activities
  • Assists with Quality Management System process audits
  • Assists in Supplier Evaluation including auditing of CMOs, testing facilities, and other support functions
  • Assists in the identification, documentation, investigation and follow up of quality events (deviations, corrective and preventive actions, etc.)
  • Assists with audits from regulatory bodies and external customers
  • Contributes to process improvement projects
  • Assists others in writing SOPs and other documents
  • Contributes to quality training development
  • Prepares supporting documentation for release of products
  • Ensures compliance with all applicable regulations (e.g. 21CFR210, 211, 600, 1271 and FDA/ICH guidelines)
  • Participates in team meetings

QA Specialist III

  • Supports management in the implementation of the Quality Management System
  • Reviews batch records and test results for completeness, accuracy and conformance to specifications
  • Reviews and releases raw materials for conformance to specifications
  • Performs in-process audits of manufacturing, analytical, and other activities
  • Performs area clearance activities
  • Assists with Quality Management System process audits
  • Assists in Supplier Evaluation including auditing of CMOs, testing facilities, and other support functions
  • Assists in the identification, documentation, investigation and follow up of quality events (deviations, corrective and preventive actions, etc.)
  • Assists with audits from regulatory bodies and external customers
  • Contributes to process improvement projects and /or is accountable to lead assigned projects
  • Writes SOPs and other documents
  • Assists in developing providing quality training
  • Prepares supporting documentation for release of products
  • Ensures compliance with all applicable regulations (e.g. 21CFR210, 211, 600, 1271 and FDA/ICH guidelines)
  • Supports management in the collection and trending of Key Performance Indicators (KPIs) and trendingParticipates in team and project meetings

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
    • QA Specialist II- In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
    • QA Specialist III- In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
  • Assurance experience in a GMP regulated environment (21CFR211, 21CFR606, and related)
  • Quality Specialist III must have demonstrated problem solving skills
  • Ability to work in a team environment with minimal supervision to complete responsibilities
  • Must be able to communicate ideas clearly and effectively with all levels
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Experience in a Phase I/II clinical trial, GMP environment with biopharmaceuticals, viral vector manufacturing and/or cell therapy products
  • Experience with Quality System Management
  • Education or experience in a STEM environment

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations