MQA Specialist II (Investigations/Deviations)

Job SummaryPerforms 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.
Salary: $79,000 - $85,000
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. 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. Read more about our benefits here.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• 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
• Propose quality initiatives determined from periodic reviews, inspectional observations, internal/external audits
• 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 cycle review confirmation for adherence to SOP requirements
• Monitoring of In-Process Controls
• Oversight of Filling/Lyophilization filling activities (including completion of Aseptic Gowning Qualification/adherence to aseptic processing guidelines)
• Finishing Activities, including Integrity Testing Verification, adherence of general inspection requirements/timelines, execution of sampling plan
• Performance of Visual Inspection (AQL) and evaluate of defects for particulate matter categorization
• Sterilization review
• Packaging oversight
• Warehousing/Storage requirement adherence
• Monitoring of Facilities and Utilities events for actions for product safety/impact
• QA Key contact to shop floor employees, providing mentorship and training on identified gaps and revisions
• On the floor QA Decision making & trouble shooting plant support where necessary for troubleshooting of manufacturing, facility and critical systems problems or special projects as needed
• 5S, internal audit & inspection preparation activities
• Collects inspection, particulate matter, AQL and re-inspection reject data on a monthly basis. Analyzes trend data
• Identify and initiate deviations in the production areas, assure products are placed on SAP hold as required and initiate and execute Action Plan requirements as needed to address investigation or compliance related activities
• Review and approval of implementation of action (CAPAs & Change Control Actions)
• Provide efficiency assessments (CAPAs & Change Control Actions)
• Provide shop-floor documentation review as well as support for batch record review for completion of checklist requirements, including critical processing steps, in order to meet production and release scheduling
• Shop-floor assessment of data governance principles
• Procedure review and approval, including periodic procedure reviews for required revisions
• Verification of Audit Trails
• 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
• reprocessing/reworking
• validation/investigation study activities
• other duties as assigned

REQUIREMENTS

• Associate degree or higher is required
• A minimum of three (3) to five (5) years' work experience required, Pharmaceutical or Food Industry experience desirable
• A High School diploma with previous related field experience or knowledge of a GMP
• A minimum of five (5) to ten (10) years' experience required, Pharmaceutical, Medical Device or Food Industry experience desirable
• Bachelor of Science degree or one (1) to three (3) years' equivalent education/professional experience preferred
• Candidates must have knowledge of the competencies as described below and complete the required training activities in the defined timelines.
• Process, Product and container knowledge & expertise
• Knowledge & experience in Microbiology & aseptic technique
• Knowledge & expertise in regulatory requirements and industry / company best practices approaches
• Competency in different computerized system (including the software and audit trails)
• Knowledge of Word/Access and Excel applications is a plus
• Knowledge & expertise in data governance & integrity and compliance requirements
• Understanding of the technology employed in production activities
• Knowledge & expertise in application of Root Cause Analysis tools & Methods
• Organizational abilities, troubleshooting capabilities, stress resilience, personal integrity
• Relevant experience in shop floor functions (production/manufacturing 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, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, 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.