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Supply Cross-Functional Analyst - Newark, DE - Operations

AstraZeneca

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Job Details

Location: Old Baltimore Pike, Brookside, New Castle County, Delaware, 19702, USA Posted: Jul 13, 2021

Job Description

Do you possess experience in electronic document management, data management, or MRP systems? If so, be a Supply Cross-Functional Analyst (SCFA) within a company that follows science and turns ideas into life-changing medicines, then this is the role for you!

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 outstanding skills with those of people from all over the globe.

The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for the global supply of complex products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities. It’s important to us that you bring your full self to work every day. To help maintain your best self, here’s a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.

The Supply Cross-Functional Analyst (SCFA) will deliver electronic document management services for cGMP documentation at the site, utilize complex, interfaced document management systems to create, revise and control various types of documentation including, but not limited to Master Batch Records, Standard Operating Procedures, and other cGMP document types as assigned.

What you will do:

  • Prepare and issue paper batch records for Packaging and Formulation in coordination with Planning and in line with production requirements.
  • Process cGMP documents in complex, automated document management systems such as TDMS (Technical Document Management System). Coordinates review and approval of documentation by subject matter experts.
  • Understand the logic of SAP, TDMS, PAS-X, and the integration with other systems.
  • Communicate effectively at all levels to both technical and non-technical audiences pertaining to SAP and TDMS.
  • Provide input into the production schedule and manages changes to ensure MBRs are prepared and available for use to meet business requirements. Responsible for highlighting exceptions and working with the Planning team to resolve.
  • Support and demonstrate Lean behaviors by actively working towards continuous improvement, consistent and simplified ways of working, process confirmations, standard work, problem-solving, and KPI reporting.
  • Participate in daily Packaging and Formulation Tier meetings, and in Weekly Planning meetings for Formulation and Packaging. Present data to the teams and act on schedule and material changes enabling the success of overall Site production goals.

Qualifications:

Education:

  • Bachelor’s degree or equivalent experience (minimum of two years)

Required:

  • Minimum of two years experience in electronic document management, data management, or MRP systems.
  • Demonstrated knowledge and/or experience working in SAP
  • Knowledge of cGMP requirements, compliance, validation, and NDA compliance. Desired:
  • Proficiency in MS Office applications.
  • Demonstrated excellent oral and written communication skills.
  • Demonstrated attention to detail with strong organizational ability.
  • Ability to work and communicate within a global, culturally diverse, and fast-paced team environment
  • Strong team-working skills
  • Evidence of developing innovative solutions
  • A consistent record of delivering results
  • Proficiency in data management applications and ERP systems such as TDMS and SAP
  • Experience in the pharmaceutical or biotechnology industry
  • Sound understanding of Good Manufacturing Practice, Safety, Health and Environment, and Standard Operating Procedures

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. Always committed to lifelong learning, growth, and development.

So, what’s next

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

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About AstraZeneca

AstraZeneca, a global pharmaceutical company, discovers, develops, manufactures and markets prescription medicines.

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