About this opportunity
Fresenius Kabi USA, LLC lists this MQA Specialist I opportunity in wilson, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Summary
Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and cGMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.
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 issue to site management, including proposed CAPAs
MQA shop-floor activities must cover the entire production and support processes which, depending upon the plant's business operations will include but not limited to:
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
Salary Range: $60,966-$85,694
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.