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Compliance Scientist I

MedImmune, LLC

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Location: Hayward, CA Posted Date: 5/6/2013 Position Type: Job Code: 7004 Required Education: Bachelors Degree

Description

The Clinical Pharmacology & DMPK Department is seeking a highly motivated individual with strong GLP experience to join the bio analytical group as a specialist working on the bio analytical report generation in support of preclinical and clinical studies. The candidate will work closely with bio analytical scientists to generate method validation and data reports for regulatory submission and will interact with QA and QAD groups to ensure GLP compliance. The candidate will also provide general support for the group in GLP compliance.

Major Duties and Responsibilities:
* Responsible for preparation of bio analytical study reports by compiling data and preparing reports
* Apply and maintain knowledge of CFR Part 11 and Part 58 and other GLP regulatory requirements
* Identify gaps and implement operational changes to ensure GLP compliance
* Monitor and ensure relevant compliance documentation is reviewed and maintained
* Work with scientific writing group for regulatory submission documents
* Assist with writing, update, review and maintenance of SOPs and other relevant documents to ensure GLP compliance
* Interact with QA to address QA audit responses
* Collaborate with QAD for compiling study binder for archiving
* Act as liaison with QA and QAD to ensure planning, scheduling, review and transfer of data, internal audit responses, study reports, study binder organization for archiving submission
* Collaborate with internal QAD and QA in maintaining adequate personnel training and learning curriculum
* Follow relevant SOPs.
* Ensure data accuracy through internal QC review of study results
* Interact with project coordinator and/or project manager to ensure meeting project timelines

~BSP

Requirements

Experience:
Good knowledge and extensive experience in GLP requirements and practices.
Special Skills/Abilities: Must have excellent scientific writing skills; knowledge of bio analytical methods; experience in writing bio analytical reports; good GLP knowledge and experience; excellent interpersonal, organization and communication skills; ability to work efficiently on multiple tasks in a fast-paced team environment; proficiency with Microsoft office software (word, excel, power point), graphic software (prism, sigma plot) and statistics software (JMP); strong attention to details.
Job Complexity: Multiple concurrent projects / tasks are expected and the ability to prioritize projects and time to meet project timelines are essential.
Supervision: Position requires working independently and on teams with minimal supervision.
Education:
BA, BS with a minimum of 8 years; MS with a minimum of 5 years; or PhD with a minimum of 2 years related work experience in an FDA regulated (GLP) or medical environment. Background in biology and experience in biotechnology / pharmaceutical industry or contract research organization are preferred.

MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.

MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.

My company shares my passion for helping to improve human health around the world.

This is My MedImmune

Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
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