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 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:
- 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:
- Batch Records and associated documentation
- Product and Component Release transactions in SAP
- Quality Investigations (Deviations, Product Complaints)
- Standard Operating Procedures
- Collaborates with other Quality professionals across the organization to ensure consistent application and execution of key quality systems
- Executes QA processes including batch record review, product and material disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
- Collaborates with other PET/assigned area members and support 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
- Performs selected quality assurance activities, dependent upon assigned area, including the following:
- Reads, understands, and follows SOP's and complies with cGMP's
- Writes new standard operating procedures or revises existing documentation utilizing document management systems
- Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents
- Supports the issuance and reconciliation of GMP documentation
- Electronic system usage with tools such as Veeva EQV, GQCLIMS, and SAP
- Reviews documented information from their functional area, reports abnormalities
- Assists supervisor by assembling metrics as requested for their functional area.
- Provides task-oriented training to Specialists.
- Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
- Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelor's degree with 3 years experience in pharmaceutical industry in roles covered by GMP oversight.
- Previous QA experience
- Basic knowledge of industry regulations and standards
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!Find out more on Social Media:
About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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