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Frederick, Maryland, United States
Onsite
Quality Assurance Specialist II
Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff.
Fueled by our aspiration to deliver accelerated growth for our company and to make people’s lives better, there’s never been a more exciting time to join the team and shape the future of AstraZeneca Operations.
Join us at AstraZeneca as a Quality Assurance Specialist within the Quality Systems group at Frederick Manufacturing Center. This role is designed to assist in all areas of quality systems, guided by the quality leads on the team. If you're ready to pioneer a new 'Quality way', this is the opportunity for you!
Position Summary
The Quality Assurance Specialist II provides Quality Assurance oversight for manufacturing and operational activities within a biopharmaceutical or pharmaceutical environment. The role is responsible for batch record review and release support, area release activities, review of electronic systems and manufacturing records, assessment of quality events, and execution of routine compliance activities.
The position works closely with Manufacturing, Quality Control, Quality Systems, Validation, Engineering, and other cross-functional teams to ensure that activities are performed in accordance with approved procedures, applicable regulations, and company quality standards. The role also contributes to continuous improvement initiatives and may support additional quality projects as assigned.
Shift: Nights, 6pm-6:30am (2-2-3 Manufacturing schedule)
Core Responsibilities
Required Education
A bachelor’s degree in biology, engineering, or a related scientific or technical field is required.
Required Experience
The successful candidate will have:
Knowledge, Skills, and Competencies
The Quality Assurance Specialist II should have a working knowledge of applicable GxP requirements, approved procedures, batch documentation practices, manufacturing processes, and quality systems. The role requires strong attention to detail and the ability to identify documentation discrepancies, assess potential quality risks, and escalate issues appropriately.
The successful candidate should demonstrate sound quality judgment, effective problem-solving skills, and the ability to work independently while collaborating with cross-functional teams. Strong written and verbal communication skills, effective time management, and the ability to manage multiple priorities are also required.
The role requires the ability to review manufacturing and electronic records, interpret process and equipment information, support deviation assessments, and contribute constructively to Lean and other continuous improvement initiatives.
The annual base pay for this position ranges from $79,890 to $119,835. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors terms of the applicable plans.
Date Posted
17-Sep-2026Closing Date
30-Sep-2026Our 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.