Careers


Immediate
Opening

Quality Assurance Specialist B-1

Responsible for assisting with the maintenance of an independent quality system to support bioanalytical lab operations. Identifying areas of regulatory risk and bring these to the attention of Quality Management. Assisting with developing and executing training for all CMIC, Inc.'s employees on quality assurance policies, programs, and initiatives and GLP regulatory requirements. Ensuring that documents are reviewed and processes conducted in accordance with company quality policies and procedures according to GLP Principles. Responsible for writing, reviewing and approving (where applicable) procedures and quality documentation. Conducting both internal and external inspections. Conducting review of study data and final reports, in support of regulatory submissions. Serving as a source of QA advice and guidance to CMIC personnel, answer questions regarding QA, procedures and training. Providing advice on GLP requirements. Reviewing and signing off protocols and schedule inspections. Conducting final report reviews and data audits in order to assure that the report is an accurate reflection of the methods used and raw data generated during the study and that the data are compliant. Reporting any review findings to relevant personnel. Conducting and reporting of quality system audits (internal and vendor). Creating, reviewing, and/or approving documents required for GLP compliance. Assisting management with awareness of compliance issues and appraising QA management of audit findings, initiating discussions with appropriate personnel as necessary. Assisting with preparation and response to customer and regulatory agency requests and inspections. Assisting with Quality aspects of Sponsor visits/audits and preparation/ issue of report of such visits/audits ensuring completion of any actions. Reviewing site quality policies and procedures and ensure consistency of content of standards with GLP requirements. Present recommendations and changes to management. Assisting with management of controlled document system. Training in GLP for Bioanalytical department and support departments (where applicable). Assisting with maintenance of the final report audit schedule. Coordinating Global Quality standards and practices.

Requirements:
Bachelor's or foreign degree equivalent in Chemistry, Biology or a related field and 3 years of experience in job offered or in a GLP or GMP or regulated lab environment. Alternative Requirements - 3 year diploma, degree or coursework in Chemistry, Biology or a related field and 5 years of experience in job offered or in a GLP or GMP or regulated lab environment. Special skills -18 months hands-on experience utilizing LC-MS-MS instrument for drugs in bodily fluids and 12 months of experience in quality assurance or quality control role In a laboratory setting.

Worksite:
2860 Forbs Ave., Hoffman Estates, IL 60192.

CMIC offers a competitive benefit package. To apply, please forward your cover letter, resume and salary requirements to HR@CMICGROUP.COM. Please reference the position title within the subject line.

Apply to:
Ms. Denise Washick
Human Resource/Administration Manager
CMIC, Inc.
2860 Forbs Ave.
Hoffman Estates, IL 60192

Posting Date:
May 4/18


Immediate
Opening

Research Analyst

We are seeking Research Analysts who will be responsible for conducting Bioanalytical lab activities in accordance with applicable methods, plans, SOPs and GLP regulatory guideline. The work includes method development, method validation and study sample analysis using LC-MS-MS techniques in a GLP regulated laboratory.

Skills and Knowledge:
1. Understand GLP requirements, SOP/SWPs and related lab procedures; safety policies and company policies.
2. Use and maintain lab equipment appropriately for assigned tasks.
3. Utilize scientific theory with proper skills (i.e. LC-MS/MS, HPLC).
4. Maintain quality execution and work.
5. Proficient troubleshooting skills.
6. Ability to handle confidential information.
7. Demonstrated effective oral and written communication skills.
8. Good team player.
9. Effective time management skills; complete work in a timely manner (i.e. maintain timelines).
10. Proficient in MS Office and to be adept at learning new systems.

Work Experience Requirements:
3+ years working in laboratory environment; regulated laboratory environment preferred.

Educational Requirements:
B.S. in related field, M.S. preferred.

CMIC offers a competitive benefit package. To apply, please forward your cover letter, resume and salary requirements to HR@CMICGROUP.COM. Please reference the position title within the subject line.