Quality Assurance Specialist

CMIC, Inc Located in: Hoffman Estates,  Illinois
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CMIC, Inc Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

CMIC, Inc., located on Hoffman Estates, IL, is a leading Contract Research Organization (CRO) and a provider specialized in bioanalytical services in support of TK/PK/PD studies for pre-clinical and clinical research and development.

The Quality Assurance Specialist is responsible for providing 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 management and senior management.  Responsible for developing and executing training for 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. 

 

CRITICAL REQUIREMENTS

  • SKills / Knowledge
    - Sound understanding of FDA regulations relating to GLP; Sound understanding of quality systems pertaining to contract research supporting Pharmaceutical industry and good documentation practices within a CRO, life science, pharmaceutical industry. - Familiar with Bioanalytical guidance. - Excellent computer skills; Word, Excel, PowerPoint and need to be adept at learning new systems. - Proven ability to handle confidential information with Strong organizational skills for filing and file maintenance. - Ability to accomplish results and complete work in a timely manner; Ability to prioritize and demonstrate attention to detail. - Be pro-active and demonstrate initiative. - Good team player and experience of dealing with complex tasks. - Demonstrated effective oral and written communication skills and excellent interpersonal skills; ability to deal with people at all levels; ability to deal and host clients, sponsors, auditors visits. - Time-management skills are required, as well as the ability to handle multiple projects.
    Education: Bachelor’s Degree; M.S. degree preferred with industry (pharmaceutical or bio lab) experience
    Experience: 7+ years working in a GLP environment with 5+ years in a quality assurance or related role
     

COMPANY INFORMATION

CMIC, Inc. (formerly JCL Bioassay USA) 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, the company provides cutting-edge capabilities and sophisticated expertise in bioanalytical method development, method validation/qualification and study sample analysis for small and large molecules. As a strategic drug development partner, CMIC helps sponsors to overcome challenges in bioanalysis with expertise, rapid turn-around-time and high quality services.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Regulatory Affairs,  Quality,  R&D / Science
Preferred Industry Background:
  CRO / Outsourced Services,  Biotechnology,  Research
Managing a team of:
N/A
Required Travel:
Not at all

Base Salary:
Confidential
Bonus:
Benefits:
CMIC, Inc. offers a competitive benefit package.
Other Compensation:
Education Required:
Undergraduate