AstraZeneca Pharmaceuticals LP Quality Compliance Specialist in Frederick, Maryland

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.

Provides leadership to the Maintenance Reliability Department and coordinates activities across other Departments. Provides leadership to the Metrology Department and coordinates activities across other Departments. Key contributor to site-wide strategy and executes cross-functional initiatives.

Main Responsibilities:

Scope

  • Responsible for assuring the quality and compliance of testing for commercial and clinical products manufactured at the facility

  • Ability to review and understand analytical data.

  • Utilizes quality system in compliance with current good manufacturing practices.

  • Working knowledge and electronic system usage with tools such as TrackWise and SAP for timely review of records, accuracy of information, availability of data/information, generation of reports.

  • Supports, participates and/or quality approves: investigation teams for non-conformances, unexpected results investigations, UIRs and EMIRs; timely development and closure of CAPAs; timely development and implementation of changes.

  • Performs on the floor inspections of QC areas to resolve issues early and to ensure compliance with SOP and regulatory requirements.

  • Author documents, participate in change review and quality approve documents according to defined procedures.

  • Supports and participates in US and ROW regulatory inspections and third-party inspections.

  • Supports/reviews QC generated data/data tables for regulatory submissions and product quality reviews.

  • Review/quality approve SAP and Procal activities when needed.

  • Understand validation principles and their application to quality approve validation protocols, validation reports and technical reports.

  • Support and manage the QC risk register. Help develop and support risk mitigation plans as needed.

Knowledge

  • Complete understanding and wide application of technical principles, theories, and concepts in the field.

  • Good understanding of cGMPs, regulatory standards and concepts.

Problem Solving

  • Provides solutions to a variety of technical problems of moderate scope and complexity.

  • Develops solutions to compliance problems of moderate scope and complexity.

Freedom to Act

  • Works under limited supervision.

  • General instructions required to perform new activities or special assignments.

  • Work requires the exercise of discretion and judgement and interpretation of established procedures.

  • Work is reviewed for soundness of technical judgement, overall adequacy and accuracy.

Impact

  • Errors can be detected and corrected but may cause moderate loss of time or may delay projects and milestones.

Interpersonal Communication

  • Frequent inter-organizational and outside customer contacts.

Education/Experience:

  • Bachelors: Scientific/Biotech/Pharmaceutical field of study, or Masters: Scientific/Biotech/Pharmaceutical field of study.

  • Bachelors: preferred 6+ years of pharmaceutical or bio pharmaceutical industry. Masters: preferred 4+ years of pharmaceutical or bio pharmaceutical industry.

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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.