Location: Research Triangle Park
Company: Biogen
to support batch disposition, review/approval of GMP procedures, protocols and reports, Gx P Quality systems-related training, identifying gaps in existing Quality systems and proposing solutions to site management. The QA Associate will perform all duties in a manner consistent with site and corporate policies, c GMP, safety, environmental and human resources policies and procedures and also adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers, and coordination of investigations impacting the RTP site.
The QA Associate may participate in internal compliance audits; backss and approve discrepancies from site, corporate, and regulatory
guidance. The QA Associate will also ensure compliance with training policies. Please note that this is a Swing Shift position and will work a traditional Manufacturing Rotation from 12pm to 12am, on a 12hr/shift schedule.
There is a 10% pay differential for this position. What You'll Do Review and approval of batch related documentation (c GMP procedures, Master Production Records, Solution Lot records, protocols, and reports) to support product disposition. Execute activities including intermediate technical writing, minor investigation support (root cause analysis/impact backssment) Support resolution of both technical and compliance issues/gaps of moderate complexity. Aide in implementation
of Quality Systems/System Improvements with guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain c GMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.
Control and release of equipment from maintenance, validation, change control and product changeover. Support and/or assists in Gx P quality systems-related training. Provide quality guidance across functions.
Who You Are The ideal candidate is curious, eager to learn, asks directed questions, and challenges assumptions. Additionally, the candidate has excellent communication/collaboration skills, logical and evidence-based thinking, and can work across all levels of the organization. Qualifications Bachelor's degree preferably in a field of science or biotechnology. 0-2 years relevant technical experience in quality oversight preferably in a biotech or medical manufacturing operation. General understanding of relevant FDA/EMA regulations. Plans schedule and arranges own activities when accomplishing objectives.
Must be able to deal with ambiguity. General understanding of Quality concepts; able to apply to process decisions Ability to develop innovative/creative solutions to issues of moderate complexity. Detail oriented. Additional Information Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine.
Together, we pioneer. Together, we thrive. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to interaction, gender identity or expression, interactionual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.
Biogen is an E-Verify Employer in the United States. PDN-9acdbd63-eb5e-4873-b664-00cc2eb3f35e
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
