Biopharmaceutical QA Specialist III

Overview

Job
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 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.

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

• 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
• Identifies and supports management of change (MOC) in the quality system
• Assists in developing providing quality training
• Prepares supporting documentation for release of products
• Ensures compliance with all applicable regulations (e.g. 21
  
  CFR
  210, 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

• 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
• In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
• Experience with in a GMP environment with biopharmaceuticals, viral vector manufacturing and/or cell therapy products
• Experience with Quality System Management
• Ability to obtain and maintain a security clearance

• Experience in a Phase I/II clinical trial
• 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
• Education or experience in a STEM environment

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

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay and benefits are fundamental to any career decision. That s why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

76,800. USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions