Are you ready to make a difference in the world of pharmaceuticals? As a QA Specialist for the Bulk Drug Substance (BDS) facility at ADMF, you will play a crucial role in ensuring the quality and compliance of our products. Your responsibility will encompass overseeing the manufacturing, testing, labeling, and storage of Bulk Drug Substances, ensuring they meet all applicable GMP regulations and product authorizations. You will be pivotal in maintaining the College Park QMS, collaborating with various departments to optimize patient supply and safeguard the company's business and global markets. This shift position operates from 7am to 7pm, offering you the chance to engage with major stakeholders and contribute to the safety, quality, and efficacy of our products.
Accountabilities
• Provide quality and cGMP input and oversight for all commercial manufacturing in the BDS facility.
• Review and approve executed batch records in accordance with Alexion’s internal procedures and GMP principles.
• Review and approve Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.
• Review and approve Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles.
• Review and approve technical support documentation (Examples include cleaning, process, method validation).
• Review and approve functional area documentation (SOPs, Work Instructions, technical reports and protocols).
• Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/controlled.
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow-up actions.
• Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management, and the Change Control Programs.
• Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
• Author, review, and approve Quality Related Procedures as required.
• Support the Supplier Management Program.
• Review and release raw materials and components as required to support manufacturing operations.
• Develop and report quality metrics.
Essential Skills/Experience
• English fluency written and spoken (the Company language).
• Strong verbal and written communication skills with well-structured communication and presentation ability.
• Ability to operate efficiently in a complex matrix organization and international environment.
• Minimum 3 years in pharmaceutical and/or biotech industry.
• Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology or Engineering).
• Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
Desirable Skills/Experience
• Strong mature leadership and interpersonal influencing skills.
At AstraZeneca, we are driven by a passion for innovation and a commitment to improving lives. Our unique culture fosters collaboration, creativity, and growth. We empower our employees with tailored development programs that align personal growth with our mission. Working here means being part of a team that is dedicated to making a meaningful impact on patients' lives. Our entrepreneurial spirit combined with the strength of a global biopharma creates an environment where ideas flourish and new thinking thrives. Join us in our journey to redefine healthcare and make a difference where it truly counts.
If you're ready to take on this exciting challenge and be part of a team that is transforming lives, we would love to hear from you!
Date Posted
10-Dec-2025Closing Date
24-Dec-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.