Quality Assurance Specialist - OTF - Philadelphia, PA - Global Operations
Are you looking to join a collaborative, team-oriented pharmaceutical/biotech company, where you will be part of an organization that puts life-saving medicines on market? Imagine using your skills in a role that is tasked with maintaining compliance and at the same time looking to innovate and improve processes in a Quality Assurance environment. If so, this role may be for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
The Philadelphia, PA site, which operates 24/7, manufactures a life-saving influenza vaccine, which is sold in the US, UK and other countries. Our product is aseptically filled into sprayers for nasal administration. The site consists of two geographic locations - a facility at Red Lion Road in NE Philadelphia has about 140 full-time employees and the Bensalem storage and distribution facility has about 5 employees. The facilities are about 8 miles apart and both are situated close to I-95, the city of Philadelphia, and Philadelphia International Airport. Operations continue year-round, with the production season being in the summer (typically May – August). Our site is highly collaborative where we show our Philly pride in all we do. We work closely together, always striving to be better every day. We have a network of employee teams who deliver many kinds of employee engagement activities, from our famous Wingbowl, to inclusion events, a site picnic, community outreach, health and wellness activities, and a green team.
The Quality Assurance Specialist (first shift) is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include but are not limited to: batch record review, change control and documentation, equipment and process validation, deviation investigations, SOPs, distribution center management, internal inspections, and regulatory interactions.
What you will do:
Maintain a high level of understanding of relevant aseptic processing and quality systems.
Perform quality assurance review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: Batch Records and associated documentation, Change Management, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports.
Support environmental monitoring of the production area with data review, personnel monitoring, sample submission.
Collaborate with site support groups on projects (capital and non-capital) and on projects (capital and non-capital)
Facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices. ) Uses lean principles to reduce waste and improve processes in Quality Operations.
Stay abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
Routine walk through audits of other departments and processes.
Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering OR
Bachelor’s degree with minimum of three (3) years experience in pharmaceutical industry in roles covered by GMP oversight OR
Associates degree with a minimum of four (4) years experience OR
A minimum of eight (8) years experience with no college degree.
Quality Systems Experience i.e. Deviation Investigation and Root Cause Analysis
Strong Knowledge of Data Integrity
Experience with Regulatory Inspections e.g. FDA, MHRA, EMA
Aseptic Processing experience
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting-edge methods and bringing unexpected teams together. Join us.
Next Steps – Apply today!
Are you ready to bring new ideas and fresh thinking to the table? We have one seat available, and we hope it’s yours. Curious to know more, then 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. Know someone who would be an excellent fit, please share this posting with them.
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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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.