Posted in Other 4 days ago.
Type: Full-Time
The ideal candidate will have strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams to support clinical manufacturing and regulatory compliance requirements. Create, revise, and manage controlled documents (SOPs, protocols, forms, etc.) within the electronic document management system (EDMS). Issue, review, and close batch production records to ensure completeness, accuracy, and compliance with GMP standards. Manage and investigate deviations, ensuring thorough root cause analysis, corrective actions, and timely closure. Support the assessment and implementation of change controls, ensuring proper documentation and impact analysis. Ensure compliance with GMP, FDA, FACT, and other regulatory standards. Support internal and external audits, including preparation, execution, and follow-up on audit findings. Oversee the review of controlled documents, deviations, CAPAs, and other quality records to ensure timely completion.
Operates and maintains a strategic research compliance program and ensures University adherence to all research compliance policies. Monitors compliance laws and regulations and updates University policies to adequately reflect new revisions. Supports all University members on research matters compliance and oversees research compliance trainings. Mitigates research compliance risks, coordinates and facilitates the Institutional Biosafety Committee (IBC) operations, shares research compliance expertise, and serves as the University's compliance expert.
The ideal candidate will have strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams to support clinical manufacturing and regulatory compliance requirements. Create, revise, and manage controlled documents (SOPs, protocols, forms, etc.) within the electronic document management system (EDMS). Issue, review, and close batch production records to ensure completeness, accuracy, and compliance with GMP standards. Manage and investigate deviations, ensuring thorough root cause analysis, corrective actions, and timely closure. Support the assessment and implementation of change controls, ensuring proper documentation and impact analysis. Ensure compliance with GMP, FDA, FACT, and other regulatory standards. Support internal and external audits, including preparation, execution, and follow-up on audit findings. Oversee the review of controlled documents, deviations, CAPAs, and other quality records to ensure timely completion.
Walking between buildings and around campus. Reading small font. Lifting up to 50 pounds as related to lab activities.
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
PI259951899
Cigna |
HIGHLANDHILLS |
Arconic |