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ASAstrazeneca logo

Astrazeneca

US - Rockville - MD, United States of America

Specialist Pharmaceutical Quality Systems.

$83.5K–125.3K/HR
As part of Laboratory Management and Stability (LMS) team, the role supports shared core responsibilities such as stability program coordination, sample flow oversight, inventory management, and the management of OOT/OOS, deviations, CAPAs, and continuous improvement initiatives. Key Responsibilities: Digital Systems Integration: Lead onboarding and configuration of laboratory digital tools across QC processes, ensuring workflows, templates, roles, and access align with operational needs and controlled documentation. Stakeholder Collaboration: Act as liaison among laboratory staff, IT, QA, and project leadership to gather requirements, address concerns, align scope, and communicate status and decisions. Training & Documentation: Develop and deliver user-focused training, SOPs, quick reference guides, and controlled templates; conduct readiness assessments and provide postgolive support. Issue Resolution & Enhancements: Troubleshoot system onboarding and usage challenges; coordinate incident triage and enhancement delivery with technical teams; maintain issue/change logs and user feedback loops. Data Integrity & Compliance: Ensure GxP aligned configuration and use across systems; uphold 21 CFR Part 11/Annex 11 controls, audit trails, role-based access, validated states, and traceability to URS/FRS/test scripts. LMS Core Operations Support: Support sample flow oversight across QC CGT labs; assist with investigations for OOT, OOS, deviations, and CAPAs; contribute to stability program; and maintain inventory management processes including Kanban room controls, min/max levels, and timely replenishment to sustain compliant operation. Audit & Inspection Support: Prepare evidence packages (training records, configuration summaries, validation status, change histories) and participate in internal/external audits and inspections. Minimum Qualifications: Associate’s degree with 3 years of relevant experience OR bachelor’s degree in Life Sciences, Chemistry, Engineering, Biotechnology, or a related field with at least 2 years of relevant experience Experience in GMP laboratory operations, pharmaceutical quality systems, manufacturing support, laboratory digital systems, equipment, materials, sample management, stability, or another regulated technical environment Working knowledge of GMP/GxP, data integrity, ALCOA+, and controlled documentation requirements Ability to learn and work across multiple LMS processes and laboratory systems, including GQCLIMS, 1Lab, MODA, Businessmap, SAP, or comparable systems Demonstrated ability to maintain accurate records, manage concurrent assignments, follow issues through closure, and escalate risks appropriately Effective written and verbal communication, stakeholder engagement, and cross-functional coordination skills The annual base pay (or hourly rate of compensation) for this position ranges from $83,504.80 - 125,257.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 12-Nov-2026 Closing Date 18-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
Pay
$83.5k–125.3k/hr
Where
US - Rockville - MD, United States of America
Work
Not stated
Type
Not stated
Posted
12 Nov, 2026
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