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Quality Specialist

2 months ago

Rochester, United States Kelly Services Full time

Contract Quality Specialist (Full benefits including PTO, Holiday Pay and Medical Insurance included)

Location: Detroit Metro Area, Michigan
Schedule: Monday-Friday 8am-5pm
Hourly Pay: $32-$34

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:
 


You will focus on developing and maintaining high standards of documentation and compliance within the Quality Assurance Validation (QAV) team
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 within validations
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





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