Lead Computer Systems Validation Specialist
2 days ago
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
The company's ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.
Job OverviewWe are seeking a highly skilled Senior Systems Analyst, QIT to join our team. The successful candidate will be responsible for leading GxP system implementation and providing data integrity and regulatory guidance and oversight throughout the system lifecycle at AmplifyBio.
Key Responsibilities:- Leading GxP System Implementation: Plan, implement, run, operate, and retire computerized systems in conformance with all applicable policies and SOPs.
- Data Integrity and Regulatory Compliance: Monitor/maintain/support health, data integrity and regulatory compliance of GxP computerized systems.
- Computerized System Validation: Develop/own technical SOPs and validation artifacts required to implement and maintain computerized systems.
- GxP Risk Assessment: Perform and author data integrity and GxP risk assessment to ensure effective requirements are captured and controls are in place to meet global regulatory requirements for GxP systems.
- Education: Minimum BA/BS in a life sciences or engineering/computer science or similar scientific discipline (advanced degree preferred).
- Experience: A minimum of 5 years' experience and in-depth knowledge of data integrity requirements and GxP computer system validation, and Part 11 requirements in a Pharmaceutical or Biotech environment including understanding software development and supporting validation IT systems in manufacturing and/or laboratories.
- Regulatory Knowledge: In-depth understanding of regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulations for assigned areas.
- Cross-Functional Experience: Proven experience in the interpretation and understanding of cGxPs for the controlled management of paper and electronic records and signatures. Cross-functional experience in QC, QA, Validation and Manufacturing is desired.
We offer a competitive compensation package including a salary of approximately $120,000 per year, plus excellent benefits such as Health, Dental, and Vision insurance, FLEXIBLE PTO policy, Generous paid parental leave, Wellness and Self-Care Programs, 401(k) match, Tuition Reimbursement, and EAP/work-life support system.
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