MQA SPECIALIST - 3rd Shift

Fresenius Kabi•Grand Island, NY

54d•$64,751 - $85,694

About The Position

This 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 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

Requirements

Minimum of High School Diploma with one (1) to three (3) years of work experience required
Knowledge & expertise in regulatory requirements and industry / company best practices approaches
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

Nice To Haves

Associate degree or High School diploma with previous related field experience or knowledge of a GMP – regulated industry preferred
Knowledge of Word/Access and Excel applications is a plus

Responsibilities

quality oversight and assistance to production processes
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 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