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Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.
The Quality Operations Specialist has a robust understanding of applicable CGMP regulations and standards and is able to apply company policies, directives, and procedures to ensure compliance by conducting investigations, review and approval of quality and production related documentation and procedures in support of internal manufacturing operations. The position advises Quality management of compliance issues, conducts quality related activities of diverse scope, and makes decisions and implements associated actions in partnership with the broader team. This role is responsible for ensuring that all aspects of product release meet analytical, manufacturing production, specifications in accordance with established quality systems by performing various and complex investigations that include thorough root cause analysis, evaluation of impact to product quality and appropriate corrective actions.
Main Responsibilities:
The Quality Operations Specialist in this role is responsible for performing various and complex investigations that ensure compliance with CGMP, implemented standard operating procedures, validated processes and established facility and quality systems.
Independently and thoroughly investigating deviations and non-conformances by gathering, analyzing and evaluating information captured through investigations, analytical test results and utility/system monitoring data as well as summarizing information and trends in investigation reports.
Understanding and being able to use various root cause and risk analysis methodology to ensure thoroughness of the investigations and corrective actions.
Understanding pharmaceutical manufacturing operations preferably biological forms and/or plasma fractionation, aseptic and packaging process as well as facility, utility and quality systems supporting those operations.
Preparing investigation reports that include investigation findings, thorough analysis of root cause and recommendations for corrective actions to eliminate recurrences and promote continuous improvement and compliance with CGMP standards.
Communicating findings and recommendations with team leaders and Senior Management. Participating in and/or leading cross-functional study teams to collect data and information. Supporting the implementation of corrective actions and their effectiveness to reduce reoccurring deviations and product/system failures.
Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures in support of investigations.
Supporting reviews of production manufacturing records to determine their compliance with the established procedures, process critical parameters and specifications established for disposition product lots.
Be able to prepare quality and technical documentation and reports by collecting, analyzing and summarizing information and trends.
Other:
Support audits conducted by clients or regulatory/ agencies.
Support regulatory submissions if applicable.
Ensure compliance of departmental procedures with global standards.
Provide quality leadership and guidance for Operations.
Perform other quality related activities and projects, as assigned.
Knowledge, Skills, and Abilities:
Focus on delivering excellent customer service.
GMP and strong quality culture oriented individual.
Excellent written and verbal communication skills.
Problem solving skills, results oriented.
Experience with pharmaceutical investigations and batch record review.
Knowledge of Microsoft Office and e-mail required.
Ability to manage time and priorities.
Requirements:
Bachelor's Degree in scientific or technical discipline or equivalent.
5 years of pharmaceutical experience in Quality or Operations department.
Experience with biologics Quality Assurance or Operations plus.
Plasma fractionation experience plus.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained. In lieu of HAZWOPER training, the employee will receive training on the requirements of the New York State hazardous waste management regulations pursuant to 6 NYCRR ยง373-3.2. All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC.
Kedrion Biopharma offers a number of benefits to 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!
Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.
Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.