MQA Specialist II

Job Summary

Performs routine audits of manufacturing areas to ensure product quality and SOP/GMP compliance at the Melrose Park Manufacturing Facility. Assists in troubleshooting manufacturing problems and inspection defects. Provides plant support for collection of data where needed, while assembling required metrics for review by facility management. Updates controlled documents, including SOPs, policies and batch records to maintain compliance in the production areas.

Responsibilities

• Drive a culture of continuous quality improvement by maintaining a shop‑floor presence.
• Act with competency, integrity and appropriately as Quality Assurance personnel and assure that required processes 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.
• Propose quality initiatives determined from periodic reviews, inspectional observations, internal/external audits.
• Perform MQA shop‑floor activities covering the entire production and support processes, including but not limited to:
  • Weighing and dispensing verification
  • Bulk solution preparation
  • Component preparation cycle review confirmation for adherence to SOP requirements
  • Monitoring of in‑process controls
  • Oversight of filling/lyophilization activities (including completion of aseptic gowning qualification and adherence to aseptic processing guidelines)
  • Finishing activities, including integrity testing verification, adherence to general inspection requirements/timelines, execution of sampling plan
  • Performance of visual inspection (AQL) and evaluation of defects for particulate matter categorization
  • Sterilization review
  • Packaging oversight
  • Warehousing/storage requirement adherence
  • Monitoring of facilities and utilities events for actions impacting product safety
• Serve as QA key contact to shop‑floor employees, providing mentorship and training on identified gaps and revisions.
• Make QA decisions and troubleshoot plant support issues, including manufacturing, facility, and critical systems problems or special projects as needed.
• Conduct 5S, internal audit, and inspection preparation activities.
• Collect inspection, particulate matter, AQL and re‑inspection reject data on a monthly basis and analyze trend data.
• Identify and initiate deviations in production areas, place products on SAP hold as required, and execute action plan requirements for investigation or compliance activities.
• Review and approve implementation of actions (CAPAs & change control actions) and provide efficiency assessments.
• Provide shop‑floor documentation review and support batch record review to meet checklist requirements, including critical processing steps for production and release scheduling.
• Assess data governance principles on the shop floor.
• Review and approve procedures, including periodic procedure reviews for required revisions.
• Verify audit trails.
• Support quality, compliance, and continuous improvement projects.
• Perform special oversight activities as needed, such as media fills, repackaging, reprocessing/reworking, validation/investigation study activities, and other duties as assigned.

Requirements

• Associate degree or higher is required.
• Minimum of three (3) to five (5) years of work experience; pharmaceutical or food industry experience desirable.
• High school diploma with related field experience or knowledge of GMP; a minimum of five (5) to ten (10) years of experience in pharmaceutical, medical device, or food industry desirable.
• Bachelor of Science degree or one (1) to three (3) years of equivalent education/professional experience preferred.
• Knowledge and expertise in:
  • Process, product, and container knowledge & expertise
  • Microbiology & aseptic technique
  • Regulatory requirements and industry/company best practices
  • Computerized systems, including software and audit trails
  • Microsoft Word, Access, and Excel (a plus)
  • Data governance, integrity, and compliance requirements
  • Technology employed in production activities
  • Root cause analysis tools and methods
  • Organizational abilities, troubleshooting capabilities, stress resilience, and personal integrity
  • Shop‑floor functions (production/manufacturing activities)

Pay

Salary: $79,000 – $85,000. Final pay determinations will depend on experience level, education, knowledge, skills, and abilities.

Benefits

• 401(k) plan with company contributions
• Paid vacation, holiday, and personal days
• Employee assistance program
• Medical, prescription drug, dental, and vision coverage
• Life insurance and disability coverage
• Wellness program

Additional Information

Employment is at‑will; both the employee and Fresenius Kabi may 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.