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Senior Quality Assurance Specialist

Company: AstraZeneca
Location: Redwood City
Posted on: January 26, 2023

Job Description:

Sr. QA Specialist - Operations - Redwood City, CAWould you like to work in a fast-paced team environment in a company that follows science and turns ideas into life-changing medicines? Are you searching for career growth and development in a quality environment with competitive salaries and benefits? If so, this position would be a great fit for you!We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people's lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalization, and sustainable practices.AstraZeneca is at an exciting time of new products and launches. We get to work with innovative and scientific products on our leading-edge end-to-end supply chain, using the latest technologies and modern facilities.In 2013, AstraZeneca acquired Pearl to expand and strengthen 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 using a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers (MDIs). Join us as a Sr. Quality Control Specialist at our Redwood City, CA site, the leading center of innovation in the WestThe Sr. QA Specialist will be responsible 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 systemsPerforms 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.Leads and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systemsCollaborate 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 projectsFacilitate teamwork 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 practicesStays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leadersSupport 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 indicatorsTraining and mentoring of junior members of the QA organization and providing QA coaching to other non-QA employees within the area supported.Minimum Qualifications:Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelors degree5 years experience in pharmaceutical industry in roles covered by GMP oversight.Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environmentExcellent problem solving, interpersonal and oral and written communication skillsStrong ability and motivation to learnPreferred Qualifications:Experience working in a LEAN manufacturing environmentKnowledge of cGMPs and FDA policies/proceduresWhy AstraZenecaAt 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 are developing new ways to work, innovative methods, and bringing unexpected teams together. Come and join our journey!Next Steps - Apply Today!Are you ready to bring new insights and fresh thinking to the table? 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.Find out more on Social Media:LinkedIn Facebook Instagram About Operations Date Posted19-Jan-2023Closing Date30-Jan-2023AstraZeneca 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 authorization and employment eligibility verification requirements.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. -SummaryLocation: US - Redwood City - CAType: Full time

Keywords: AstraZeneca, Redwood City , Senior Quality Assurance Specialist, Other , Redwood City, California

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