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 II 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!

Shift: Nights, 6pm-6:30am (3-3-2 schedule)

Accountabilities:
As a Quality Assurance Specialist II, you will perform selected quality assurance activities, including reading, understanding, and following SOP’s and complying with cGMP’s. You will write new standard operating procedures or revise existing documentation utilizing document management systems. You will also support the issuance and reconciliation of GMP documentation and use electronic system tools such as Trackwise, EQV, FileTrail, Power BI and SAP. 

You will review documented information from your functional area, report abnormalities, assist in the implementation of new processes, and provide task-oriented training to Specialists. You will also initiate and/or review and approve minor deviations; complete tasks related to CAPA and Change Control action items. 

Essential Skills/Experience:
• Minimum Bachelor's degree; biology, engineering or science-related field preferred.
• 2-4 years industry experience  

Desirable Skills/Experience:
• 2 years experience in QA preferred

The annual base pay (or hourly rate of compensation) for this position ranges from $79,879.20 to $119,818.80 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

Date Posted

25-Jul-2025

Closing Date

28-Jul-2025

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 embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.