QA Specialist II/III

Job ID: req2900
Employee Type: exempt full-time
Division: Biopharmaceutical Development Program
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

This position description does not represent a specific job but represents a sourcing announcement for current and future open positions. Our positions span a wide range of skills, so candidates who express an interest may be considered for upcoming positions at Frederick National Laboratory for Cancer Research.

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.

Assists and supports the organization with initial compliance monitoring of conformance to established quality assurance processes and standards for manufacturing and production of biopharmaceutical and cell therapy products. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures.

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
  

KEY ROLES/RESPONSIBILITIES (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 trending
• Participates 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
  

• Specialist II, QA - In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
• Specialist III, QA- In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
  

• 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

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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