Quality Specliast (Pharmaceuticals)

Quality Specliast (Pharmaceuticals)


Job ID: 8987869

Detroit, MI, US

Scientific

Bachelors Degree

Full Time, Temp to Hire

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Detroit, MI, US

Experienced (Non-Manager)

Full Time, Temp to Hire

Biotechnology/Pharmaceuticals

On-site

Scientific

Bachelors Degree

First Shift (Day)

Job details

Contract Quality Specialist

Location: Detroit Metro Area, Michigan
Schedule: Monday-Friday 8am-5pm
Hourly Pay: $30-$32

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

8987869

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