MQA Specialist II (Investigations/Deviations)

Summary

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.Salary: $79,000 - $85,000Final 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 INCUMBENTDrive a culture of continuous quality improvement by on the shop-floor presenceAct with competency, integrity and appropriately as Quality Assurance personnel and assure that the processes required are adhered toAuthorized to stop production activities and contain materials and/or products with immediate effect where Critical Deviations are notedEscalate Isolated and Systemic issue to site management, including proposed CAPAsPropose quality initiatives determined from periodic reviews, inspectional observations, internal/external auditsMQA 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 verificationBulk Solution PreparationComponent Preparation cycle review confirmation for adherence to SOP requirementsMonitoring of In-Process ControlsOversight 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 planPerformance of Visual Inspection (AQL) and evaluate of defects for particulate matter categorizationSterilization reviewPackaging oversightWarehousing/Storage requirement adherenceMonitoring of Facilities and Utilities events for actions for product safety/impactQA Key contact to shop floor employees, providing mentorship and training on identified gaps and revisionsOn the floor QA Decision making & trouble shooting plant support where necessary for troubleshooting of manufacturing, facility and critical systems problems or special projects as needed5S, internal audit & inspection preparation activitiesCollects inspection, particulate matter, AQL and re-inspection reject data on a monthly basis. Analyzes trend dataIdentify 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 activitiesReview 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 schedulingShop-floor assessment of data governance principlesProcedure review and approval, including periodic procedure reviews for required revisionsVerification of Audit TrailsSupport quality and compliance and continuous Improvement projectsSpecial oversight activities based on case by case demand to include but not limited to:media fillsrepackagingreprocessing/reworkingvalidation/investigation study activitiesother duties as assignedREQUIREMENTSAssociate degree or higher is requiredA minimum of three (3) to five (5) years' work experience required, Pharmaceutical or Food Industry experience desirableA High School diploma with previous related field experience or knowledge of a GMPA minimum of five (5) to ten (10) years' experience required, Pharmaceutical, Medical Device or Food Industry experience desirableBachelor of Science degree or one (1) to three (3) years' equivalent education/professional experience preferredCandidates must have knowledge of the competencies as described below and complete the required training activities in the defined timelines.Process, Product and container knowledge & expertiseKnowledge & experience in Microbiology & aseptic techniqueKnowledge & expertise in regulatory requirements and industry / company best practices approachesCompetency in different computerized system (including the software and audit trails)Knowledge of Word/Access and Excel applications is a plusKnowledge & expertise in data governance & integrity and compliance requirementsUnderstanding of the technology employed in production activitiesKnowledge & expertise in application of Root Cause Analysis tools & MethodsOrganizational abilities, troubleshooting capabilities, stress resilience, personal integrityRelevant experience in shop floor functions (production/manufacturing activities)Additional Information We offer an excellent salary and benefits package including medical, dental andvision 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 permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.#J-18808-Ljbffr

Job Description

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.Salary: $79,000 - $85,000Final 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 INCUMBENTDrive a culture of continuous quality improvement by on the shop-floor presenceAct with competency, integrity and appropriately as Quality Assurance personnel and assure that the processes required are adhered toAuthorized to stop production activities and contain materials and/or products with immediate effect where Critical Deviations are notedEscalate Isolated and Systemic issue to site management, including proposed CAPAsPropose quality initiatives determined from periodic reviews, inspectional observations, internal/external auditsMQA 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 verificationBulk Solution PreparationComponent Preparation cycle review confirmation for adherence to SOP requirementsMonitoring of In-Process ControlsOversight 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 planPerformance of Visual Inspection (AQL) and evaluate of defects for particulate matter categorizationSterilization reviewPackaging oversightWarehousing/Storage requirement adherenceMonitoring of Facilities and Utilities events for actions for product safety/impactQA Key contact to shop floor employees, providing mentorship and training on identified gaps and revisionsOn the floor QA Decision making & trouble shooting plant support where necessary for troubleshooting of manufacturing, facility and critical systems problems or special projects as needed5S, internal audit & inspection preparation activitiesCollects inspection, particulate matter, AQL and re-inspection reject data on a monthly basis. Analyzes trend dataIdentify 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 activitiesReview 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 schedulingShop-floor assessment of data governance principlesProcedure review and approval, including periodic procedure reviews for required revisionsVerification of Audit TrailsSupport quality and compliance and continuous Improvement projectsSpecial oversight activities based on case by case demand to include but not limited to:media fillsrepackagingreprocessing/reworkingvalidation/investigation study activitiesother duties as assignedREQUIREMENTSAssociate degree or higher is requiredA minimum of three (3) to five (5) years' work experience required, Pharmaceutical or Food Industry experience desirableA High School diploma with previous related field experience or knowledge of a GMPA minimum of five (5) to ten (10) years' experience required, Pharmaceutical, Medical Device or Food Industry experience desirableBachelor of Science degree or one (1) to three (3) years' equivalent education/professional experience preferredCandidates must have knowledge of the competencies as described below and complete the required training activities in the defined timelines.Process, Product and container knowledge & expertiseKnowledge & experience in Microbiology & aseptic techniqueKnowledge & expertise in regulatory requirements and industry / company best practices approachesCompetency in different computerized system (including the software and audit trails)Knowledge of Word/Access and Excel applications is a plusKnowledge & expertise in data governance & integrity and compliance requirementsUnderstanding of the technology employed in production activitiesKnowledge & expertise in application of Root Cause Analysis tools & MethodsOrganizational abilities, troubleshooting capabilities, stress resilience, personal integrityRelevant experience in shop floor functions (production/manufacturing activities)Additional Information We offer an excellent salary and benefits package including medical, dental andvision 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 permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.#J-18808-Ljbffr