Job detailsContract Quality Specialist (Full benefits including PTO, Holiday Pay and Medical Insurance included!)Location: Detroit Metro Area, MichiganSchedule: Monday-Friday 8am-5pmHourly Pay: $32-$34Overview: 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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