QA Specialist - Quality Systems

Location
Frederick, MD, USA
Posted
Oct 23, 2018
Ref
JR37-70098
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

KEY ROLES/RESPONSIBILITIES

Reporting to the QA Manager of Compliance/Training, the QA Specialist will:
  • Support the maintenance and improvement to quality system processes, procedures, and GMP related activities
  • Assist with GEMBA walks, process audits, and/or compliance audits, as required
  • Write thorough, comprehensive and detailed analysis and investigations
  • Apply Root Cause Analysis (RCA) tools to identify systemic root causes and propose corrective actions to prevent reoccurrence
  • Apply RCA and Risk Management analysis to propose preventive actions and process improvements
  • Work directly with VCMP internal departments to ensure follow-up of quality issues
  • Assist in the development of solutions to moderately complex problems
  • Assist departments in the initiation and documentation of corrective action and/or preventive action (CAPA) plans related to GMP processes and GxP electronic systems. May also serve as the lead for CAPA execution
  • Facilitate cross-functional meetings with internal and external parties, as required
  • Write and/or implement changes to controlled documents, as needed
  • Assist in the development and improvement of training programs regarding all aspects of improving quality
  • Submit periodic status notifications (i.e. email, quality board, meetings, etc.) to leads, coordinators, and functional area approvers
  • Support management with the tracking of quality system metrics for adherence to organizational or department targets and escalate issues, when necessary

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
  • Possession of a Bachelor's degree from an accredited college/university in a scientific discipline according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to educational requirements, a minimum of five (5) years job related experience, or a minimum of 3 years of experience in a cGMP environment
  • Experience in Quality, conducting investigations and/or developing/generating quality system metrics
  • Experience in supporting management review and/or developing/generating quality system metrics
  • Strong understanding of US and International regulations and requirements such as CFR, ISO, ICH, WHO, etc.
  • Experience with GxP Electronic Systems, e.g. TrackWise, Content Server, RAM, LIMS, etc.
  • Experience with implementation/improvement of quality systems
  • Must be able to recognize routine deviations from accepted practice
  • With guidance, exercise judgement within well-defined and established procedures and/or practices to determine appropriate and acceptable action(s)
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:
  • ASQ or other auditor training
  • Risk Management knowledge and/or training
  • Knowledge of quality control (QC) and/or biologics manufacturing
  • Good written and verbal communication skills to interact with all facets of the organization.

Expected Competencies:
  • Career-level (fully competent) experienced professional able to carry out a full range of professional duties, by working independently and receiving minimal guidance
  • Provides professional know-how to enhance the knowledge and skill base of the organization
  • Accountable for meeting own target which will impact the discipline
  • Impact is limited to the achievement of short- to medium-term goals
  • Contributes to delivery of discipline / department goals through personal effort or through influence over team members
  • In-depth knowledge of principles and practices within a professional discipline
  • Uses best practices and knowledge of internal or external business issues to improve products or services and suggests variations in approach
  • Devises solutions based on limited information and uses past experience, evaluation, and interpretation to identify solutions or to adapt existing approaches to resolve issues; which may impact the longer term
  • Solves complex problems; takes a new perspective using existing solutions
  • Requires strong multicultural awareness to appropriately deliver messages and adapts style to differing audiences
  • Acts as a resource for colleagues with less experience; may direct the work of other staff members


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