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Quality Assurance - Clinical I
17 Month Contract
W 2 ONLY
In compliance with current good manufacturing practices, the Product Complaint Associate is responsible for supporting the complaint handling Quality system through the timely assessment, processing, distribution of information, and communication of alleged product quality defects for all client drug products within the scope of the Global Product Quality Complaints (GPQC) Group.
• Triage all incoming reports in order to immediately identify the following:
• Product and medical device complaints
• Complaints that require expedited processing due to potential compliance issues.
• Responsible for recording and processing quality complaint information received into the global complaint database. This includes:
• Entering new complaint records
• Determine when a complaint should be investigated or recorded for trending purposes only.
• Determine when a complaint sample should be retrieved for evaluation.
• Issue response letters to complainants regarding product complaints received.
• Contact reporters either by email or phone, as necessary, to gather additional complaint information.
• Complete daily workload while maintaining consistent, right first time quality work and compliance with established procedures and timelines. This may require the Associate to triage and process a minimum number of reports on a daily basis as specified by the US Complaints Operations managers.
• Understanding of Code of Federal Regulation (CFR) good manufacturing practices for finished
pharmaceuticals with emphasis on complaint handling requirements.
• Understanding/knowledge of over-the-counter, pharmaceutical, and medical device products, packaging, and labeling with emphasis on complaint handling requirements. *Experience with sterile and medical device product within a healthcare setting and/or manufacturing and packaging is a plus.
• Experience with triage activities that include but are not limited to identifying product and medical device complaints and the necessary decision-making skills that align with procedures.
• Experience with computer systems including database, spreadsheet and word processing applications.
• Excellent oral and written communication skills that align with providing optimal levels of customer service, providing accurate product information, and compliance with good manufacturing practices and procedures.
• Possess organizational skills/flexibility/teamwork in order to effectively prioritize daily workload and consistent maintain compliance with procedure timelines.
• Must have ability to address obstacles with energy and determination and exhibit commitment to change and passion for the client's best interests.
What is the minimum education experience required?: Education requirements:
• Bachelor's/Master's Degree: A minimum of one years' experience within the healthcare or pharmaceutical setting.
• Associate Degree or equivalent: A minimum of two years' experience within a healthcare or pharmaceutical setting.
• PhD: This position does not require this level of education.
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.