MQA SPECIALIST I (NIGHTS)

Fresenius Kabi • Wilson, NC

320d • $50,000 - $60,000

About The Position

Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in response to deviations noted. Assures compliance to SOP’s and cGMP’s. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.

Requirements

• Minimum of High School Diploma with one (1) to three (3) years of work experience required
• Associate degree or High School diploma with previous related field experience or knowledge of a GMP – regulated industry preferred
• Knowledge & expertise in regulatory requirements and industry / company best practices approaches
• Competency in different computerized systems (including software)
• Knowledge of Word/Access and Excel applications is a plus
• Aptitude for understanding of the technology employed in production activities
• Organizational abilities, troubleshooting capabilities, stress resilience, personal integrity
• Relevant work experience/functions (production activities)

Responsibilities

• Drive a culture of continuous quality improvement by on the shop-floor presence
• Act with competency, integrity and appropriately as Quality Assurance personnel and assure that the processes required are adhered to
• Authorized to stop production activities and contain materials and/or products with immediate effect where Critical Deviations are noted
• Escalate Isolated and Systemic issues to site management, including proposed CAPAs
• MQA shop-floor activities must cover the entire production and support processes
• Weighing and Dispensing verification
• Bulk Solution Preparation
• Component Preparation identification and verification
• Monitoring of In-Process Controls
• Oversight of Filling/Lyophilization activities (including completion of Aseptic Gowning Qualification)
• Finishing Activities, including Integrity Testing Verification, adherence of general inspection requirements/timelines, execution of sampling plan
• Performance of Visual Inspection (AQL)
• Packaging oversight
• Warehousing/Storage requirement adherence
• Monitoring of Facilities and Utilities per required parameters
• QA key contact to shop floor employees
• On the floor QA contact to escalate issues and provide real-time documentation requirements/trouble shooting analysis
• Participate in 5S activities
• Support in investigations & root-cause analyses (incidents & investigations)
• Shop-floor documentation review of MBRs and logbooks for GMP and procedural compliance
• Support quality and compliance and continuous Improvement projects
• Special oversight activities based on case by case demand to include but not limited to: media fills, repackaging, reworking, validation/investigation study activities, other duties as assigned

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits including medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED