Quality Engineer (QA Risk Management Specialist)

Proclinical is currently recruiting for a Quality Engineer (QA Risk Management Specialist) for a multinational biopharmaceutical company located in Raritan, NJ. As the Quality Engineer, you will oversee and lead quality activities for risk management, continuous improvement efforts, annual product review and other quality system functions.

Job Responsibilities:

• Provide QA oversight, support and robust guidance for site risk management; review and approve site risk documents
• Lead and facilitate the creation of pFMEAs in support of process improvement projects
• Lead site specific quality system continuous improvement activities resulting in compliance with enterprise standards and global procedures; Such as, site risk register process, global document gap assessments, adopting new or revised regulatory requirements, and good documentation practices
• Drive alignment and efficiencies between local and global processes through building positive relationships across functions, to meet unified business objectives and resulting in an effective quality system for the site
• Support risk management practices and applicable documentation during audits and inspections
• Design and deliver training for specific quality system topics, in both classroom setting and individual interactions
• Support the annual product review process
• Ensure and maintain a state of inspection readiness
• Support quality systems process related to CAPA, Change Control or Audit actions
• Manage cross-functional projects with many stakeholders
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
• Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
• Other duties will be assigned, as necessary

Skills and Requirements:

• Minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required
• Minimum of 4 years relevant work experience in risk management is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
• Strong interpersonal and written/oral communication skills
• Ability to quickly process complex information and often make critical decisions with limited information
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities
• Proficient in applying process excellence tools and methodologies
• Ability to independently be responsible for a portfolio of ongoing projects
• Ability to pay attention to details and follow the procedures
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision
• Good written and verbal communication skills are required
• Ability to summarize and present results, and experience with team-based collaborations is a requirement
• Ability to work with and lead others in a team environment
• Experience developing and setting long-term objectives
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing
• Ability to identify/remediate gaps in processes or systems
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968 or m.phelan@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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