QA Complaint Specialist
: Job Details :

Job SummaryThe QA Complaint Specialist is responsible for working with Quality Complaint Intake Team (Regional QA), US Vigilance & other departments to facilitate the completion of investigations of quality complaints, service (shipping) complaints and manufacturing site ADE investigations, along with the review and closure of documentation, for third party manufactured products.This position impacts all US Third Party Manufacturing (TPM) and Supply Chain (SC) Quality activities relative to investigations of product quality complaints, which ensure the facility's GMP/FDA compliance status. It is essential thatduties 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 USA, Fresenius Kabi partners, and with FK-USA's third party manufacturing contacts and lead meetings/communications with internal and external partners.*Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (e.g., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.*Salary Range: $62,000-$70,000*Final 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.Responsibilities

*Works with Quality Complaint Intake Team (Regional QA), US Vigilance, and third party manufacturers' Quality personnel to ensure timely completion of product quality complaint investigations and manufacturing site investigations relevant to ADEs. Also works with Customer Service, SC Compliance and Packaging Development personnel to ensure timely completion of shipping (service) complaint reports.

oMonitors complaint intake to ensure initial impact assessment is completed within 3 days of awareness for product quality complaints and within 5 days of awareness for service (shipping) complaints.

*Assesses complaints for field alert and biological product deviation reporting.

*Authors initial impact assessments and final complaint investigations in GCMW related to third party manufactured product, in a timely manner.

*Authors initial impact assessments and final investigations for shipping complaints received for products distributed by US Distribution Centers operations, in a timely manner.

*Serves as back-up to Quality Complaint Intake Team (Regional QA) for NAM complaint initiation and review activities in GCMW.

*Provides information and interacts with multiple departments and management in completing investigations.

oProactively manages complaint record timelines to meet 60 day target for product quality complaints and 30 day target for shipping complaints. If record extension is needed, requests in a timely manner.

*Appropriately prioritizes work, focusing on timelines and assessing urgency of issues

*Prepares and manages shipments of returned customer samples to the manufacturing sites to assist with investigations and communicates sample tracking information.

*Evaluates complaints for trends including lot, product code and product family trends and complaints per million.

oParticipates in cross functional internal/external team meetings to discuss lot and CPM trends and documents agenda, action items and outcome.

*Assists with compilation and preparation of complaint trend metrics for monthly management review.

oProactively identifies and communicates negative trends.

*Uses systems such as global Complaint Management System (gCMW) and KabiTrack (TrackWise) to receive, document and close complaint records.

*Assists in the review and revision of Standard Operating Procedures applicable to product complaint processing.

*Serves as back-up for coordination of product distribution holds for US warehouses based on product complaint impact assessments. (SAP process, initiation of and completion of distribution hold forms and notifications to appropriate personnel).

*Supports internal audits and external regulatory agency audits requirements as well as internal audit functions.

*Supports or participates in quality projects and teams to implement quality systems and improvements to meet regulatory or company requirements.

Requirements

*Bachelor's Degree required; in a scientific discipline, preferred.

* Minimum 3 years of relevant experience.

*Excellent communication, writing, and reasoning skills.

*Experience with Microsoft Office programs is required; experience with TrackWise is preferred.

*Prior technical report writing experience and exposure to investigations and/or product quality complaints, preferred.

*Must be able to recognize and resolve discrepancies and deficiencies.

*Must be able to manage time effectively in a fast-paced pharmaceutical environment.

*Must be able to effectively work with all levels of personnel within Fresenius Kabi, and with contract manufacturing contacts.

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, andwellness 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.

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