At MiMedx, our purpose starts with helping patients heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care products combined with a promising clinical pipeline, we are committed to making a transformative impact on the lives of patients we serve globally.
Will you join us on this journey?
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 complexity and scope (examples are a balance, rotary shaker, sieve shaker, or equipment with 0-2 process inputs or controllers)
Develop, write, and execute equipment qualifications of limited complexity and scope
Develop, write, and execute validation protocols of limited 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 assisting with desk audits and on-site quality system and process audits
BS degree in Science, Engineering, or related field
0-3 years of experience working in an FDA-regulated industry
Prefer cGMP pharmaceutical industry, biologics industry experience; medical device or tissue processing industries considered
Knowledge of FDA, AATB, ISO, and other state/federal/international regulations and standards
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
The work is typically performed in a normal office environment. Role routinely uses standard office equipment.