Good Documentation Practice Monitor OVERNIGHTS 6PM-6AM

Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.

Job Summary

Be the frontline guardian of quality and compliance on the manufacturing floor. As a Good Documentation Practices (GDP) Monitor, you will play a critical real-time role ensuring data integrity, regulatory compliance, and high-quality documentation. Partnering closely with Manufacturing and Operations teams, you will help identify and correct documentation issues as they happen—preventing errors before they impact product quality or release timelines while promoting a culture of accuracy and accountability.

What you'll do

• Perform real-time reviews of batch records, logbooks, cleaning logs, and production documentation to ensure compliance with GDP, cGMP, and ALCOA principles.
• Identify documentation errors, omissions, and discrepancies as they occur and guide operators through compliant corrections.
• Collaborate directly with Manufacturing Operators to reinforce proper documentation practices and ensure accuracy at the source.
• Proactively detect trends or recurring issues that could lead to deviations or non-conformances and partner with teams to resolve them.
• Maintain a strong presence on the manufacturing floor as a subject matter expert, providing coaching and constructive feedback to improve documentation habits.
• Track and categorize documentation errors and share insights with Quality and Operations leadership to support continuous improvement initiatives.
• Ensure all shop floor documentation remains inspection-ready for internal and external audits at all timesSupport a clean, safe, and compliant working environment aligned with cGMP and company standards.
• Participate in training and collaborate across departments to ensure consistent adherence to procedures and regulatory expectations.
  
  

Qualifications And Need-to-know

• High School Diploma or GED required; Associate’s or Bachelor’s degree in a scientific, technical, or related field preferred
• 2–4 years of experience in a regulated manufacturing environment (pharmaceutical, biotech, medical device, or food/dietary supplements)
• Strong working knowledge of FDA 21 CFR Parts 210/211, cGMP, and GDP principlesDemonstrated attention to detail with the ability to identify documentation errors in fast-paced environments
• Strong interpersonal and communication skills with the ability to provide constructive feedback effectively
• Basic math skills and ability to perform calculations related to batch records
• Proficiency with Microsoft Office and standard computer applications
• Flexibility to work extended hours and collaborate across multiple departments as needed
• Ability to work in a manufacturing environment, including occasional exposure to cold conditions
  
  

Work Schedule: Monday-Friday 6:00PM-6:00AM 6 Month Assignment (availbility needed on weekends)

Pay Range: $20.00-$25.00/HR

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications.

Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:

• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual
• and much more!
  
  

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com.

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.