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Quality Assurance Packaging Specialist Jobs

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Quality Assurance Packaging Specialist
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Join BioMarin's QA team in Cork as a Packaging Specialist. Provide vital Quality oversight for pharmaceutical packaging, ensuring GMP compliance and process improvement. This role requires 5+ years of QA experience in pharma/biotech and strong knowledge of FDA/EMEA regulations. Drive quality init...
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Ireland , Cork
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Not provided
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BioMarin Pharmaceutical
Expiration Date
Until further notice
Pursue a critical career at the intersection of product integrity and consumer safety with Quality Assurance Packaging Specialist jobs. This specialized profession is essential within highly regulated industries like pharmaceuticals, biotechnology, medical devices, food and beverage, and cosmetics. Professionals in this role serve as the guardians of the final product presentation, ensuring that packaging not only protects the contents but also complies with stringent global standards and regulations. Their work is a vital link in the supply chain, guaranteeing that products reach customers in perfect condition, with correct labeling, and in full compliance. A Quality Assurance Packaging Specialist typically operates within a Quality department, providing oversight and expertise for all packaging operations. Their day-to-day responsibilities are diverse and crucial. They review and approve packaging batch records and associated documentation to ensure every step of the process is correctly executed and documented. A core function involves providing real-time quality direction on the packaging floor, working directly with manufacturing and operations teams to address issues, minimize disruptions, and ensure timelines are met. They are responsible for managing quality events, such as non-conformances or deviations, by conducting thorough investigations, identifying root causes, and overseeing the implementation of effective corrective and preventive actions (CAPAs). Furthermore, they review and approve change controls related to packaging materials, processes, or equipment, ensuring all modifications are assessed for quality impact. They also play a key role in writing, reviewing, and approving Standard Operating Procedures (SOPs) and often contribute to internal and external audit processes specific to the packaging area. The typical skill set for these roles combines technical knowledge with sharp analytical and interpersonal abilities. A bachelor’s degree in a life science, engineering, or a related field is commonly required, along with several years of experience in a quality function within a regulated industry. In-depth knowledge of Good Manufacturing Practices (GMP), FDA, and EMEA regulations as they pertain to packaging is fundamental. Specialists must possess excellent attention to detail, strong organizational skills, and the ability to prioritize tasks in a fast-paced environment. Proficiency in problem-solving, root cause analysis, and decision-making is essential. They must be effective communicators, capable of coaching staff and collaborating with cross-functional teams while maintaining a firm stance on compliance. Proficiency with standard office software and quality management systems is also a standard requirement. For individuals passionate about quality systems, regulatory compliance, and hands-on problem-solving, Quality Assurance Packaging Specialist jobs offer a rewarding and stable career path with a direct impact on product excellence and patient or consumer well-being.

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