Quality Control Associate Scientist / Scientist I - Operations

Astrazeneca Frederick , MD 21705

Posted 2 weeks ago

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 exceptional skills with those of people from all over the globe. As aQuality Control Associate Scientist / Scientist I in Frederick, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Main Responsibilities

Scope:

  • Conducts or participates in multiple simultaneous projects that are complex and technically demanding within the area/field of QC.

  • Initiates, implements, plans, directs, and executes investigations to resolve deviations, understand analytical trends, and/or improve process performance.

  • Responsible for balancing day-to-day technical support for QC labs and longer-term projects or investigations.

  • Assumes leadership responsibility for analytical tech transfer programs, operating as receiving and/or sending unit.

  • Facilitates global analytical tech transfer programs, accommodating country-specific requirements to ensure successful transfer.

  • Responsible for maintaining technical expertise on several analytical areas and instrumentation (ex. HPLC, ELISA, BioAssay, electrophoretic assays) as assigned.

  • Possesses working knowledge on process unit operations within a section of the manufacturing process (either upstream, downstream, or fill/pack) as assigned.

  • Works under general supervision of higher-level scientist or manager.

  • Makes detailed observations, analyzes data, and interprets results.

  • Responsible for writing/reviewing sections of regulatory documents.

  • Maintains up to date familiarity with applicable regulations and regulatory guidance associated with analytical method design/transfer/validation requirements.

  • Serves as subject matter expert for various analytical themes on behalf of QC, routinely engaging with regulatory agencies during inspections.

  • Effectively presents results at internal meetings.

  • May participate at external scientific meetings.

  • Indirectly supervise lower-level associates.

Knowledge:

  • Wide application of principles, theories and concepts in field of interest plus working knowledge of other related disciplines.

  • Maintains high level of expertise through review of scientific literature and attendance at scientific conferences.

Problem Solving:

  • Provides solutions to a wide-range of difficult problems, which requires creative thinking.

  • Solutions are imaginative, thorough and practicable.

  • Applies a working knowledge of related technical disciplines.

Freedom to Act:

  • Works under general direction. Independently determines and develops approach to solutions.

  • Anticipates and resolves priority conflicts.

  • Work is reviewed against objectives for accuracy, completeness, and soundness of judgment.

  • Impact:

  • Decisions or recommendations consistently result in project advancement and favorable budget outcomes.

  • Conducts independent research, development or support programs.

  • Has begun generating internal or external documents of value to the company.

  • Has performed as a contributing member of one or more project teams.

Interpersonal Communication:

  • Coordinates efforts of others within the department or company.

  • May have frequent collaboration within and outside of the company.

  • Has some contact with customers and Suppliers.

Supervisory/Management Skills:

  • Accomplishes tasks mainly as an individual contributor, but also provides technical guidance to less experienced staff. May direct activities of lower level staff. Leads project teams.

Education:

  • BS Required, MS or PhD Preferred.

Experience:

  • PhD-0-4 years relevant experience,
  • MS-6 + years, or BS-8 + years.

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.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.


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