Overview
Documentation Practice Monitor POSITION Jobs in Melville, USA at Kedrion Biopharma Inc.
Position: Good Documentation Practice Monitor DAYS 6AM-4PM CONTRACT POSITION
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 times. Support 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 principles.
Demonstrated 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.
Pay range: $20.00–$25.00.
Schedule:
Wednesday–Saturday 6 AM–4 PM.
Benefits
- Medical, vision, and dental insurance
- Life and AD&D insurance
- Paid holidays
- PTO accrual
- and much more!
EEO Statement
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.
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Title: Documentation Practice Monitor POSITION
Company: Kedrion Biopharma Inc.
Location: Melville, USA
Category:
