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 a key quality partner in a fast-paced pharmaceutical manufacturing environment.
- The Quality Assurance Associate supports quality oversight activities across manufacturing operations to help ensure compliance with established procedures, regulatory requirements, and GMP standards.
Working directly on the production floor, this role collaborates closely with Quality and Operations teams to monitor manufacturing activities, conduct routine inspections, review production documentation, and identify compliance concerns in real time. This position offers an excellent opportunity to build experience in quality operations while contributing to the production of life-changing therapies.
- What you'll do
- + Provide on-floor quality support for manufacturing operations within a GMP-regulated environment.
+ Monitor batch processing activities to ensure compliance with approved procedures, batch records, and cGMP requirements. + Conduct routine inspections of production areas, equipment, systems, utilities, and facilities using established checklists. + Review production logbooks and batch records, including verification of critical process parameters. + Support plasma and component inspection activities as required. + Identify, document, and communicate quality observations in real time to support operational compliance. + Track and trend documentation observations to support site quality metrics and continuous improvement initiatives. + Initiate and document minor non-conformance reports. + Support Return to Service activities and associated quality documentation. + Review critical system and utility alarms to assess compliance and operational impact. + Perform reviews of work orders, preventive maintenance records, and calibration documentation. + Assist with the development, revision, and maintenance of SOPs and other GMP-controlled documents. + Participate in cross-functional projects and departmental initiatives to support quality and operational excellence. + Support investigations, deviations, change controls, corrective actions, and other quality system activities as assigned. + Maintain accurate, complete, and timely documentation in accordance with GMP and GDP requirements. + Adhere to all company safety policies, procedures, and regulatory standards. + Collaborate effectively with Manufacturing, Quality Assurance, Engineering, and other functional teams. + Perform additional duties and assignments as needed to support site operations.
Daytime Role:
06:00 am - 06:00 pm (Alternating days including weekends)- Qualifications and need-to-know
- + College degree preferred or equivalent combination of education and relevant experience required.
+ Experience in a pharmaceutical manufacturing, Quality, or Operations environment preferred. + Experience supporting biologics manufacturing, Quality Assurance, or production operations is a plus. + Knowledge of GMP and GDP regulations and working in a regulated pharmaceutical environment. + Experience with plasma fractionation, aseptic filling, or labeling operations is advantageous. + Experience supporting pharmaceutical investigations, deviations, or quality systems is preferred. + Strong attention to detail and ability to review manufacturing documentation accurately. + Effective written and verbal communication skills. + Demonstrated problem-solving and organizational skills. + Proficiency with Microsoft Office applications and email systems. + Ability to work collaboratively in a team-based manufacturing environment. + Commitment to workplace safety, compliance, and quality standards. + Ability to complete training requirements and follow approved procedures and SOPs. _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
•. 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.
