MQA Specialist - 2nd Shift

Fresenius Kabi USA, LLC; Grandyle Village (NY); On-site; USD 61,000 - 85,000; Full time

Job summary

Fresenius Kabi USA, LLC seeks a Quality Assurance professional to oversee manufacturing quality on the shop floor, ensuring compliance with SOPs and cGMPs. The role supports production processes, labs, and deviations.

You will drive continuous improvement, authorize stop-work for critical deviations, and escalate issues with proposed CAPAs. Strong knowledge of regulatory requirements and GMP, plus experience with documentation and 5S, is required.

Qualifications

• Knowledge of regulatory requirements and industry best practices.
• Experience with GMP-regulated industry preferred.
• Knowledge of computerized systems (Word/Access and Excel a plus).
• Aptitude for understanding technology used in production activities.
• Organizational, troubleshooting, and stress management skills.
• Relevant experience in production activities.

Responsibilities

• Provide quality oversight of production processes and assist departments and laboratories.
• Recommend corrective actions for deviations and ensure SOPs and cGMP compliance.
• Maintain finished product reserve sampling and FDA retention sample storage areas.
• Drive continuous quality improvement on the shop floor.
• Authorize stop production for critical deviations and escalate issues with proposed CAPAs.
• QA on shop-floor activities across weighing, bulk solution prep, filling, finishing, packaging, and warehousing.

Skills

Quality assurance

5S activities

Investigations

Root-cause analysis

Troubleshooting

Organizational abilities

Documentation

CAPA

Education

High School Diploma

Associate degree

Tools

Word

Access

Excel

Job description

Responsibilities

• 2nd Shift is 2:00 PM to 10:30 PM, Monday through Friday


• Salary Range: $60,966 - 85,000


• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.


• Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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.

• 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 elevate 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
  
  
  
  

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
  
  
  
  

• Candidates must have knowledge of the competencies as described below and complete the required training activities in the defined timelines:
  
  
  
  • Knowledge & expertise in regulatory requirements and industry / company best practices approaches
  
  
  • Competency in different computerized system (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)
  
  
  
  

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.