Quality Operations Specialist

Kedrion Biopharma GmbH; Melville (NY); Hybrid; USD 28,000 - 34,000; Full time

Benefits offered by this job

Medical insurance

Vision & Dental

Life & AD&D insurance

Paid holidays

PTO accrual

Job summary

Kedrion Biopharma Inc. is seeking a GDP Monitor to support real-time data integrity on the manufacturing floor in Melville, NY. You will review batch records, logs, and production documents, guiding operators to correct deviations promptly and stay in regulatory compliance.

Ideal candidates have 2–4 years in a regulated setting, strong attention to detail, and the ability to work with cross-functional teams to improve documentation practices and audit readiness.

Qualifications

• High school diploma or GED required; science/technical degree preferred.
• 2–4 years in a regulated manufacturing environment (pharma/biotech/medical devices).
• Strong attention to detail with ability to identify documentation errors.
• Excellent communication and collaboration across departments.
• Proficiency with Microsoft Office and basic math calculations.

Responsibilities

• Perform real-time reviews of batch records, logbooks, and production docs for GDP/cGMP compliance.
• Identify errors and guide operators through compliant corrections on the floor.
• Collaborate with Manufacturing Operators to reinforce proper documentation practices.
• Detect trends to prevent deviations and support continuous improvement.
• Maintain inspection-ready documentation for audits and assist training efforts.

Skills

Attention to detail

Strong communication skills

GDP knowledge

cGMP knowledge

Regulatory compliance

Education

High School Diploma or GED

Associate/Bachelor preferred

Tools

Microsoft Office

Job description

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

The Good Documentation Practices (GDP) Monitor plays a critical, real-time role on the manufacturing floor, acting as the frontline defense for data integrity and regulatory compliance. Working directly alongside Manufacturing and Operations teams, this role is responsible for reviewing batch records, logbooks, and production documents as they are generated. Rather than just auditing after the fact, the GDP Monitor actively partners with Manufacturing Operators to catch errors early, facilitate immediate and compliant corrections, and mitigate potential deviations before they impact product quality or release timelines.

Pay Range: $20.00/hr - $25.00/hr

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 always remains inspection-ready for internal and external audits.
• 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.
• May perform other duties as assigned.
• Specific training plan to be provided.

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.

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 [e-mail] .

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.