Contract Quality Specialist
Location: Detroit Metro Area, Michigan
Overview: The Quality Specialist, Systems monitors, tracks, and trends Non-Conformances (NCR), CAPA (Corrective and Preventive Actions), complaints, and other Quality Systems. They assess the risk associated with NCRs and escalate issues as needed.
Key Responsibilities:
Monitor, track, and trend NCR, CAPA, and complaints
Assess risk levels of NCRs, escalate issues to management, and ensure timely completion of Quality Systems tasks
Assist in preparing materials for Quality Council and Management Review
Perform and evaluate effectiveness checks for CAPA
Qualifications:
Minimum of a Bachelor’s degree in life sciences or related field, with 3+ years of experience in the pharmaceutical industry; or Master's degree with 1+ year of relevant experience
Knowledge of FDA regulations, cGMP, OSHA, DEA, 21-CFR-210, 21-CFR-211, and ICH Guidelines
Strong communication skills, technical writing ability, and proficiency in quality management systems
Focus on quality, integrity, problem-solving, and decision-making skills
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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