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Manufacturing Investigator - Philadelphia, PA - Operations

Местоположение Филадельфия, Пенсильвания, США Идентификатор вакансии R-104570 Дата публикации 04/06/2021

Do you have experience in investigations and route cause analysis with a passion for understanding technical issues and driving process improvement within a company that follows science and turns ideas into life-changing medicines? If so, the Manufacturing Investigator position with AstraZeneca in Philadelphia, PA might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

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 Manufacturing Investigator provides advanced support to the Manufacturing Operation under minimal supervision and pro-actively works with QA, QC, Process Facilitators, Manufacturing, Science and Technology, Engineering, and Maintenance. Responsible for performance data such as Pareto of deviations and root causes, deviations/lot by cell and shift, cycle time to close deviations/CAPAs, which are posted on visual factory and discussed at shift meetings. In addition, this position is responsible for working with Process Leads, QA, QC, and manufacturing teams to resolve any trends in errors that would delay the batch release or batch record turn around

What you will do:

  • Serve as the primary investigator for deviation events, support OOS investigations in manufacturing, and create CAPAs.

  • Manage and increase the effectiveness and efficiency of manufacturing operations through improvements via a reduction of deviations, documentation errors, and hold up of batch records.

  • Ensure all assigned projects and deliverables (i.e. corrective actions, deviations, kaizen action items, CAPA, etc…) are completed per commitment date.

  • Drive initiatives in the cell teams and manufacturing operations that contribute to a long-term operational excellence culture.

  • Support all Kaizen events and help implement solutions to drive results based on trending and data analysis.

Qualifications:

Education:

  • BS Degree in engineering, science, or equivalent experience

Essentials:

  • Minimum of five years of manufacturing, quality, and/or FDA regulatory experience.

  • Relevant knowledge of cGMP, lean principles, and regulatory requirements.

Desired:

  • Green belt preferred. Strong consideration will be given to candidates with previous aseptic processing experience in the bio/pharmaceutical industry. Competent in the delivery of interpersonal and analytical skills.

  • Minimum of seven years of manufacturing, quality, and/or FDA regulatory experience) preferred

  • Minimum of three years of proven manufacturing, quality, and/or FDA compliance investigatory writing experience

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

The challenge to stay ahead in rapidly changing markets is what keeps us driving forward, as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve.

So, what's next?

Are you ready to bring new ideas and fresh thinking to the table? Wonderful! We have one seat available, and we hope it’s yours.

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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.

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