Quality Control Manager - Redwood City, CA
Quality Control Manager - 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 upmost 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
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 utilizing a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers (MDIs).
The Quality Control Manager will provide expert technical and analytical leadership, advice and direction to the Quality Control function including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology.
This individual should have strong knowledge and understanding of analytical chemistry and laboratory instrumentation, as well as Good Manufacturing Practice/Good Laboratory Practice. Must have a comprehensive understanding of the Quality Control function and its role and importance to the wider business.
What you'll do:
- Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product
- Establish visual tracking and other tools to enhance Audit readiness and trend analysis
- Oversee completion of laboratory investigations and studies
- Lead process improvement activities and teams to meet strategic goals
- Manage schedules, attendance, vacation time, and staffing coverage for the team
- Monitor key performance indicators to meet strategic goals
- Perform quality audits to ensure devices used are in proper working condition
- Develop and track department budget
- Manage the performance of others, including performance/merit reviews, professional development, and disciplinary action
- Develop and communicate a vision for the function in alignment with overall organizational goals
- Oversee that outgoing product is reviewed, documented, and releasable
- Ensure that final product meets specifications of market to which it is being sent
- Inspect production output to identify issues and determine how performance matched up with the targeted plan
- Interpret FDA (Food and Drug Administration) and other OUS (Outside US) regulations for site
- Serve as SME (subject matter expert) and/or primary point of contact for various safety initiatives
- Bachelor’s Degree, preferably in science-related discipline (for example, chemistry, microbiology, pharmacy).
- Minimum of seven (7) years’ experience in biopharmaceutical development, Quality or manufacturing,
- Minimum three (3) years of supervisory/management experience.
- Extensive experience in a Good Manufacturing Practice environment
- Knowledge and a comprehensive understanding of the principles and concepts of compliance management and Good Manufacturing Practice / Good Laboratory Practice
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.
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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.