- Solid understanding of FDA regulations relating to GLP, 21 CFR Part 58 and Part 11.
- Sound understanding of quality systems pertaining to contract research supporting Pharmaceutical industry and good documentation practices within a CRO, life science, and pharmaceutical industry.
- Management of multiple teams.
- Time-management skills are required, as well as the ability to handle multiple projects.
- Demonstrated effective oral and written communication skills and excellent interpersonal skills; ability to deal with people at all levels.
- Ability to prioritize and complete work in a timely fashion and demonstrate attention to detail.
- Ability to handle confidential information with organizational skills for filing and file maintenance.
- Be pro-active and demonstrate initiative.
- Good team player and experience of dealing with complex tasks.
- Excellent computer skills; Word, Excel, PowerPoint and need to be adept at learning new systems.
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Quality Assurance Manager - Hoffman Estates, United States - CMIC
Description
Job DescriptionJob Description
CMIC, Inc.
(CMIC Group's US Bioanalytical CRO) is a leading CRO and a provider specialized in bioanalytical services in support of TK/PK studies for pre-clinical and clinical developments.
Located in Hoffman Estates, IL, (Northwest suburb of Chicago) we provide cutting-edge capabilities and sophisticated expertise in bioanalytical method development, methodvalidation/qualification
and study sample analysis for small and large molecules.
We are currently seeking a Quality Assurance Manager.
Responsibilities includes providing oversight of the QA and QC business units through leadership in development and implementation of an independent quality system to support bioanalytical lab operations.
Identify areas of regulatory risk and bring these to the attention of lab and senior management.Responsible for developing and executing training for all CMIC, Inc.'s employees on quality assurance policies, programs, and initiatives and GLP regulatory requirements.
Ensure that documents are reviewed and processes conducted and carried out are in accordance with company quality policies and procedures and in compliance with GLP.
Responsible for writing, reviewing, and approving (where applicable) procedures and quality documentation. Conduct review of study data and final reports, in support of regulatory submissions. Mentoring Quality Assurance Team and monitor new development of regulations.3+ years working in a GLP environment with 2+ years in a quality assurance or related role.
Team Management Experience.
Company Description CMIC is a Bioanalytical Contract Research Organization (CRO) offering small molecule, large molecule, Biomarkers and Oligonucleotides. CMIC has become a leading CRO in Japan and North America.
Located in Hoffman Estates, Illinois, our world-class laboratory mirrors our Japanese laboratories to provide seamless method and knowledge transfer. Purpose-built in 2008 to maximize efficiencies and provide our scientists with a world-class quality environment.
Company Description
CMIC is a Bioanalytical Contract Research Organization (CRO) offering small molecule, large molecule, Biomarkers and Oligonucleotides.
CMIC has become a leading CRO in Japan and North America.\r\rLocated in Hoffman Estates, Illinois, our world-class laboratory mirrors our Japanese laboratories to provide seamless method and knowledge transfer.
Purpose-built in 2008 to maximize efficiencies and provide our scientists with a world-class quality environment.#J-18808-Ljbffr
