Job Description

POSITION SUMMARY:

Qualify equipment and validate processes and systems used to process tissue products or to manufacture biologic drug products or medical device products.  Ensure compliance with all applicable principles, regulatory requirements, company policies, and standards.   Provide support to the development of new products and changes made to existing products, such as protocol preparation, scheduling, data collection, data review, statistical analysis, investigations, root cause analysis, corrective and preventive actions, report compilation, auditing, and supplier qualifications.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage projects, efforts, and changes of limited to moderate complexity and scope (examples are an autoclave, tray/band/bar sealer, or equipment with several process inputs or controllers)
• Develop, write, and execute equipment qualifications of limited to moderate complexity and scope
• Develop, write, and execute validation protocols of limited to moderate complexity and scope for processes, facilities, products, and software
• Generate and resolve protocol discrepancies and/or deviations that may arise as part of validation execution
• Provide quality input to manufacturing and development personnel regarding product and process verification and validation requirements
• Assist and support validation activities and process development activities wherever needed
• Assist with or lead internal investigations of corrective and preventive action issues in relation to process deviations
• Participate in continuous improvement activities that directly impact performance measures
• Provide support to product development and manufacturing for design control planning and design transfer activities
• Assist with internal and external audit activities
• Provide support for supplier quality management activities by conducting desk audits and on-site quality system and process audits, training to become a lead auditor, training for CQA
• Act as a subject matter expert in at least one quality or technical area (e.g. sterilization, statistics, DOE, etc.)

PROBLEM SOLVING:

• Performs advanced areas of work for the professional field
• Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems.
• Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results

DECISION MAKING/SCOPE OF AUTHORITY:

• Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions
• Receives technical guidance only on unusual or complex problems or issues
• May manage elements/portions of a budget/project

SPAN OF CONTROL/COMPLEXITY:

• Seasoned professional contributor with responsibility for an advanced area of work in the professional field
• May be responsible for entire projects or functions having modest scope/impact or portions of projects having considerable scope/impact to department results

EDUCATION/EXPERIENCE:

• BS degree in Science, Engineering, or related field
• 3-6 years of experience working in an FDA-regulated industry
• Prefer cGMP pharmaceutical industry, biologics industry experience; medical device or tissue processing industries considered
• Prefer progress towards obtaining CQE
• Prefer progress towards obtaining CQA
• Knowledge of FDA, AATB, ISO, and other state/federal/international regulations and standards

SKILLS/COMPETENCIES:

• Excellent oral, written, and interpersonal communication skills
• Proficient in Microsoft Office (Excel, Word, etc.) and Minitab
• Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
• Must show aptitude to develop appropriate skills needed for the job

WORK ENVIRONMENT:

The work is typically performed in a normal office environment.  Role routinely uses standard office equipment.