MQA Specialist I

301044 Fresenius Kabi USA, LLC; Kansas; On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC in Kansas is seeking a Quality Assurance professional responsible for quality oversight and assistance to production processes, supporting departments and laboratories. The role recommends corrective action in response to deviations and ensures compliance with SOPs and cGMPs.

Maintains proper sampling and FDA retention sample storage areas. You will drive a culture of continuous improvement on the shop floor, have authority to stop production when critical deviations

Qualifications

• Quality assurance background required.
• Knowledge of cGMPs and SOPs.
• Ability to document and escalate issues clearly.

Responsibilities

• Drive a culture of continuous quality improvement by on the shop-floor presence.
• Act with competency and integrity as Quality Assurance personnel and ensure adherence to required processes.
• Authorized to stop production activities and contain materials and/or products with immediate effect when Critical Deviations are noted.
• Escalate isolated and systemic issues to site management, including proposed CAPAs.
• QA shop-floor activities cover weighing/dispensing verification, bulk/component prep, in-process controls, and visual inspections.

Job description

Job Summary

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 elevate 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

Salary Range: $60,966-$85,694 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

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.

Fresenius Kabi 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