Compliance Specialist II
With one of the largest, most robust pipelines in the industry — including more than 120 research projects and product candidates — MedImmune comprises nearly half of AstraZeneca’s overall R&D portfolio. We are focused on three core therapeutic areas: Oncology; Respiratory, Inflammation and Autoimmune; and Cardiovascular and Metabolic Disease.
The Compliance Specialist is responsible for ensuring the data generated and reported by the Clinical Immunology and Bioanalysis (CIB) laboratory are accurate and in compliance with GLPs, good documentation practices (GDP), and internal procedures.
Major Duties and Responsibilities:
- Manage QC processes and maintain QC schedule and workload
- Perform QC of bioanalytical data and reports (ie. method validation, GLP phase reports) to verify accuracy, adherence to good documentation practices and compliance with applicable SOP
- Write, review, and revise SOPs, manuals, and reports associated with QC processes/procedures
- Coordinate and conduct periodic audit of personnel GLP training records, data and documentation (ie. archived data/reports, electronic data repository), equipment maintenance records, and sample inventory (ie. GLP specimens/reagents, human biological samples)
- Compile, maintain, and report quality metrics to track performance of quality systems, identify potential areas of concern, and support continous process improvement initiatives to enhance operational efficiency and compliance to GLP regulations and procedures
- Participate in regulatory inspection readiness effort in collaboration with Translational Science Quality department
- Provide QC trending analysis support to monitor and ensure performance bioanalytical methods
- Interact with QA to address QA audit responses
Application of knowledge of FDA regulations (GLPs 21CFR58; electronic records 21CFR11) and good documentation practices in creating, implementing, and conducting QC processes in a GLP laboratory or equivalent to ensure data quality and regulatory compliance highly desired.
BA / BS in Biology or other life science with a minimum of 8 years; MS with a minimum of 6 years related work experience.
- Organization, attention to detail, accurate documentation skills and the ability to comply with regulatory requirements and internal procedures
- Understanding of FDA regulations (GLPs 21CFR58; electronic records 21CFR11) and strong good documentation practices
- Experience in immunoassays and LC-MS preferred
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team
- Fluency in English with excellent grammar and spelling
- Proficiency with Microsoft Office (Word, Excel, PowerPoint); familiarity with SoftMax (Molecular Devices) and OpenLAB ECM (Agilent) a plus
Job Complexity: Multiple concurrent projects I tasks are expected and the ability to prioritize projects and time to meet project timelines are essential.
Level of Supervision Required: Position requires working independently and on teams with minimal supervision.
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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