MQA SPECIALIST - 3rd Shift

Fresenius Kabi USA•Grand Island, NY

About The Position

Job Summary • 3rd Shift is 10 PM to 6:30 AM, Monday - Friday nights • Salary Range: $60,966 - 85,694 annually • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Responsibilities 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 - Associate degree or High School diploma with previous related field experience or knowledge of a GMP – regulated industry preferred 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 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. 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. Fresenius Kabi (www.CaringForLife.us) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address – messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using “Fresenius-kaabi.com” which of course includes an extra “a” in “Kabi.” Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your driver’s license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at [email protected]. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.

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
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

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