Quality Control Senior Analyst - Operations
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.
Our Frederick, MD facility creates life-changing medicines for people around the world! We make a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.
The Frederick Manufacturing Center is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives. We are also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick, and Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019.
- Reviews documented information from their functional area, reports abnormalities
- Prepares and executes protocols (including IOQ/PQ as applicable) , authors technical reports, as needed. Interacts, and coordinates with Regulatory, QA and other departments for protocol approval/amendments.
- Perform level 0 problem solving investigation.
- Works on complex problems where analysis of situations or data requires an in-depth evaluation.
- Acts independently to develop procedures on new assignments. Assists the implementation of new technology.
- Assists supervisor by assembling QC metrics as requested for their functional area.
- Provides direction and training to analysts.
- Owns QIMS records in Trackwise and DCRs in Document Management System.
- Performs biennial review of and approves process SOPs.
- Represents Supervisor at meetings, etc as requested and performs selected Supervisor duties as requested.
- Represents QC on site committees such as Safety, Health and Environment, etc.
- Proposes and implements process, test method and other efficiencies as approved by supervisors/technical specialists.
- Bachelor’s degree in Scientific, Biotech, Pharmaceutical or similar field of study OR 4 additional years of work experience in lieu of degree
- MS degree with 2+ years of experience
- Preferred 4+ years of analytical testing experience in pharmaceutical or biopharmaceutical industry
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.