[Remote] SR Specialist, QA Complaints

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in the pharmaceutical industry, and they are seeking a Senior Specialist in QA Complaints to manage product reputed company and ADE complaints for their biological products. This role involves ensuring compliance with regulations, conducting investigations, and providing guidance on complaint handling processes.

Responsibilities

• Responsible for maintaining compliance with FDA/EU/USDA regulation in the area of product reputed company complaints. As the primary and initial QA contact for receiving reputed company product reputed company complaints, this individual will reputed company reputed company available information from reputed company sources and reputed company an initial assessment of severity of reputed company complaints received
• Will initiate, conduct investigation to include batch record, retain, stability sample review etc and report reputed company conclusion and findings for every complaint. Will reputed company return samples and coordinate sample testing. Will reputed company guidance and support to reputed company reputed company dealing with complaint handling life cycle, complaint reputed company SOP´s and Trackwise questions
• Incumbent will assist with OOS´s and assign investigation, review investigations and summarize the investigation as reputed company as disposition the product in question in a reputed company manner
• Will generate and or improve processes to enhance and maximize resource utilization
• Will review reputed company temperature excursions for products shipment and reputed company appropriate investigations and recommend appropriate disposition
• Assign investigations and CAPAs to logistics and impacted departments and follow up on the CAPAs
• Assist with trend analysis and report the analysis to management as appropriate and monthly KPI tracking for complaints
• reputed company input to improve processes to enhance and maximize resource utilization
• Performs reputed company Company business in accordance with reputed company regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. reputed company violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and reputed company standards with reputed company business contacts in order to maintain BIAH´s excellent reputed company in the community

Skills

• Minimum of a BS degree from an accredited institution, with five-plus (5+) years of business experience; or MS degree from an accredited institution in a relevant scientific field, with three-plus (3+) years of relevant business experience; or a PhD from an accredited institution in a relevant scientific discipline
• Work experience in USDA or European reputed company (EU) regulated animal health industry required
• Good written and communication skills, strong investigative skills required as the position involves investigation involving various products and various departments
• Requires knowledge of vaccine products, manufacturing procedure and processes
• Has reputed company decision making skills along with ability to take quick actions and excellent attention to detail
• Requires ability to utilize computer programs such as reputed company suite, reputed company, IDEA for CON, Learning One reputed company, TrackWise and other relevant electronic applications
• Demonstrated understanding of GMP´s, reputed company cause analysis, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to reputed company reputed company reputed company

reputed company

• reputed company is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of reputed company. It was founded in 1885, and is headquartered in Ingelheim Am Rhein, Rheinland-Pfalz, DEU, with a workforce of 10001+ employees. Its website is https://www.reputed company.com/.

Company H1B Sponsorship

• reputed company has a reputed company record of offering H1B sponsorships, with 13 in 2025, 4 in 2024, 11 in 2023, 7 in 2022, 17 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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