Sr. QA Specialist - Operations - Redwood City, CA
Sr. QA Specialist - Operations - Redwood City, CA
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 exceptional skills with those of people from all over the globe.
AstraZeneca in Redwood City, CA has expanded and strengthened its respiratory products portfolio, We have made strides in bringing therapies to asthma patients. Our mission and vision are to develop differentiated therapeutics for widely prevalent respiratory disease conditions, including chronic obstructive pulmonary disease (COPD), by utilizing a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers (MDIs).
The Sr. QA Specialist will be responsible for 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 release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.
What you will do:
- Maintains a high level of understanding of relevant production processes and quality systems
- Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned:
- Change Requests
- Batch Records and associated documentation
- Product and Component Release transactions in SAP
- Quality Investigations (Deviations, Product Complaints)
- Validation Plans, Protocols and Reports
- Standard Operating Procedures
- Leads and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
- Interfaces with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
- Facilitate collaboration and influences other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
- Support as a subject matter expert all inspection (i.e. self-inspection, corporate, regulatory agency)
- Leads in innovation and digitalization of data analysis and report creation on quality metrics and key performance indicators
- Training and mentoring of junior members of the QA organization and providing QA coaching to other non-QA employees within the area supported
- Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelor’s degree with 5 years experience in pharmaceutical industry in roles covered by GMP oversight.
- Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment
- Experience working in a LEAN manufacturing environment
- Knowledge of cGMPs and FDA policies/procedures
- Knowledgeable with Quality systems (i.e. Quality Risk Management, Complaints handling)
- Excellent problem solving, interpersonal and oral and written communication skills
- Strong ability and motivation to learn
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 ambitious - 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. Interested? Come and join our journey.
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
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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.