Overview
QA Consultant Jobs in Gaithersburg, MD at Azzur Group
Title: QA Consultant
Company: Azzur Group
Location: Gaithersburg, MD
Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you’re a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!
We are seeking a highly skilled CQV Engineer to join our consulting team. The CQV Engineer will play a crucial role in ensuring the successful commissioning, qualification, and validation of facilities, equipment, and processes in the pharmaceutical, biotechnology, and medical device industries. The ideal candidate will possess strong technical expertise, project management skills, and a thorough understanding of regulatory requirements
As a Quality Assurance Consultant, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The individual will be responsible for but not limited to quality oversight of clinical biologics GMP laboratories.
Responsibilities:
Reads, understands, and follows SOPs and complies with cGMP
Writes and/or revise Quality documentation utilizing electronic document management systems
Maintains routine presence in the QC and analytical laboratories
Supports the disposition of intermediates and finished products through timely evaluation of Certificate of Analysis, laboratory results and other cGMP documents
Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans etc., that are submitted to QA for approval
Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in the electronic quality management system
Participates in self-inspection audit program
Supports continuous improvement efforts
Participates in cross-functional Tier meetings
Other duties as assigned
Requirements
3+ years applicable experience with B.S. degree in Science, Engineering or related technical field
Understanding of basic microbiological and analytical quality control assays and methodologies
Ability to work in a fast-paced environment across multiple technical functions
Ability to make decisions under pressure that balance patient safety, compliance and supply
Experience:
Essential:
Drug Substance/Drug Product testing and/or quality experience
Experience in managing quality records, including but not limited to, deviations, change controls and CAPA
Desirable:
M.S degree in Science, Engineering or related technical field
Drug Substance and Drug Product testing experience in analytical, immunoassay and/or microbiology
Lean, Six Sigma and/or Continuous Improvement experience
Benefits
Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k)
Life Insurance (Basic, Voluntary & AD&D)
Paid Time Off (Vacation, Sick & Public Holidays)
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
