Quality Complaint Coordinator
3.
6 Melrose Park, IL Melrose Park, IL Full-time Full-time $60,000 - $80,000 a year $60,000 - $80,000 a year Job Summary This is a customer facing role that performs intake calls and obtains follow-up information for product quality complaints.
Manages and distributes product quality complaint call information requests within the US Production Units, Third-Party Manufacturing Quality Assurance groups and Quality Compliant Specialist team to facilitate the completion of complaint investigations.
Enters data into complaint management systems.
Ensures compliance with cGMP, SOP, and FDA regulations.
This position impacts all product quality complaints for the NAM region (products released to US market by the 3 NAM PUs and TPM Quality Assurance), which plays a role in ensuring the region's GMP/FDA compliance status.
It is essential that duties are performed promptly and accurately with special attention to each incident as the product's safety, quality, identity, purity and potency could be impacted.
Must be able to effectively work with all levels of personnel within Fresenius Kabi and Fresenius Kabi partners.
Directly communicates with Fresenius Kabi customers in North America.
This position has no direct reports.
Responsibilities The Quality Complaint Coordinator manages and allocates call information requests for product quality complaints within the US production Units, Third Party Manufacturing Quality Assurance groups, and the Quality specialists.
Assists with monitoring of the regional complaints shared mailbox and NAM compliant hotline Routes and reports adverse drug reactions and medical inquires to appropriate department Performs intake of product quality complaints and ensures that quality complaints are addressed promptly and handled accurately in accordance with SOPs and quality agreements.
Ensures timely initiation of product quality complaints in gCMW.
Reports to management regularly on product complaints.
Uses standard intake questions for certain products and complaint types.
Communicates with customers and documents all communication promptly and accurately.
Works with the Production Units and Third-Party Manufacturing Quality groups to ensure follow-up with the customer, aiding in the timely investigation of each complaint.
Supports process changes needed for new product launches and new portfolios.
Maintains the historical and current files for all complaint intake related documents.
Ensures compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems as per roles and responsibilities.
May back-up Complaint Specialists for actions including:
Assists with complaint investigations related to third party manufactured product, in a timely manner.
Authors investigations for shipping complaints received for products distributed to the US market, in a timely manner.
Drafts initial and final impact assessments and reviews completed investigations by third party manufacturers.
Enters data and manages complaint records in KabiTrack and gCMW All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities Requirements Bachelor's Degree required (scientific discipline preferred).
2 +years of relevant experience.
Excellent communication, writing, and reasoning skills.
Experience with Microsoft Office programs is required.
Prior technical report writing experience and/or exposure to investigations and product quality complaints preferred.
Must be able to comprehend scientific/technical descriptions of analytical specification and methods, manufacturing controls and processes.
Must be able to recognize and resolve discrepancies and deficiencies.
Must be able to manage time effectively in a fast-paced pharmaceutical environment.
Maintains a courteous, cheerful and cooperative demeanor at all times, with both internal and external customers 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 match, 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.
Job Type:
Full-time Pay:
$60,000.
00 - $80,000.
00 per year
Benefits:
401(k) Dental insurance Flexible spending account Health insurance Paid time off Parental leave Tuition reimbursement Vision insurance Schedule:
8 hour shift Day shift Monday to Friday Work Location:
Hybrid remote in Melrose Park, IL 60160.
Estimated Salary: $20 to $28 per hour based on qualifications.
6 Melrose Park, IL Melrose Park, IL Full-time Full-time $60,000 - $80,000 a year $60,000 - $80,000 a year Job Summary This is a customer facing role that performs intake calls and obtains follow-up information for product quality complaints.
Manages and distributes product quality complaint call information requests within the US Production Units, Third-Party Manufacturing Quality Assurance groups and Quality Compliant Specialist team to facilitate the completion of complaint investigations.
Enters data into complaint management systems.
Ensures compliance with cGMP, SOP, and FDA regulations.
This position impacts all product quality complaints for the NAM region (products released to US market by the 3 NAM PUs and TPM Quality Assurance), which plays a role in ensuring the region's GMP/FDA compliance status.
It is essential that duties are performed promptly and accurately with special attention to each incident as the product's safety, quality, identity, purity and potency could be impacted.
Must be able to effectively work with all levels of personnel within Fresenius Kabi and Fresenius Kabi partners.
Directly communicates with Fresenius Kabi customers in North America.
This position has no direct reports.
Responsibilities The Quality Complaint Coordinator manages and allocates call information requests for product quality complaints within the US production Units, Third Party Manufacturing Quality Assurance groups, and the Quality specialists.
Assists with monitoring of the regional complaints shared mailbox and NAM compliant hotline Routes and reports adverse drug reactions and medical inquires to appropriate department Performs intake of product quality complaints and ensures that quality complaints are addressed promptly and handled accurately in accordance with SOPs and quality agreements.
Ensures timely initiation of product quality complaints in gCMW.
Reports to management regularly on product complaints.
Uses standard intake questions for certain products and complaint types.
Communicates with customers and documents all communication promptly and accurately.
Works with the Production Units and Third-Party Manufacturing Quality groups to ensure follow-up with the customer, aiding in the timely investigation of each complaint.
Supports process changes needed for new product launches and new portfolios.
Maintains the historical and current files for all complaint intake related documents.
Ensures compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems as per roles and responsibilities.
May back-up Complaint Specialists for actions including:
Assists with complaint investigations related to third party manufactured product, in a timely manner.
Authors investigations for shipping complaints received for products distributed to the US market, in a timely manner.
Drafts initial and final impact assessments and reviews completed investigations by third party manufacturers.
Enters data and manages complaint records in KabiTrack and gCMW All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities Requirements Bachelor's Degree required (scientific discipline preferred).
2 +years of relevant experience.
Excellent communication, writing, and reasoning skills.
Experience with Microsoft Office programs is required.
Prior technical report writing experience and/or exposure to investigations and product quality complaints preferred.
Must be able to comprehend scientific/technical descriptions of analytical specification and methods, manufacturing controls and processes.
Must be able to recognize and resolve discrepancies and deficiencies.
Must be able to manage time effectively in a fast-paced pharmaceutical environment.
Maintains a courteous, cheerful and cooperative demeanor at all times, with both internal and external customers 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 match, 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.
Job Type:
Full-time Pay:
$60,000.
00 - $80,000.
00 per year
Benefits:
401(k) Dental insurance Flexible spending account Health insurance Paid time off Parental leave Tuition reimbursement Vision insurance Schedule:
8 hour shift Day shift Monday to Friday Work Location:
Hybrid remote in Melrose Park, IL 60160.
Estimated Salary: $20 to $28 per hour based on qualifications.
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