AstraZeneca Pharmaceuticals LP QA Specialist II - ATS - (Frederick, MD) in Frederick, Maryland

If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a QA Specialist II in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Main Duties and Responsibilities

Scope

  • You will be responsible for assuring the quality of commercial and clinical products manufactured at the facility.

  • You will support functional areas including manufacturing, facilities and other Quality departments.

  • You will implement quality policies for process improvements.

  • You will utilize quality assurance system in compliance with current good manufacturing practices.

  • You will maintain database, generate routine reports.

  • You will manage electronic system usage with tools such as Trackwise and SAP.

  • You will have the ability to learn the use of Operational Excellence tools such as DMAIC and root cause analysis.

  • You will have the ability to communicate and work effectively with internal customers.

  • You will demonstrate technical ability and skills in assigned work area to include product, process and/or testing knowledge.

  • You will have the ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers.

  • You will support collection of metrics to track performance.

  • You will support departmental projects.

In addition to the above, a Quality Specialist II working within Quality-ATS would also perform:

  • You will support the evaluation and disposition of process intermediates through timely review of batch records, laboratory results and other GMP documents.

  • You will perform on the floor inspections of the production areas to resolve issues early and to ensure compliance with SOP and regulatory requirements.

  • You will act as back-up for other Quality Units in off-hours. You will re-issue batch record pages; issue logbook pages, SPRs and MPRs.

  • You will perform on the floor SPR/MPR and autoclave review.

  • You will perform PCS alarm review.

  • You will assist in product changeover, zone promotions, placing QA hold tags, logbook extensions.

  • You will routinely provide compliance guidance to Manufacturing team.

Essential Requirements

Education

  • AS/BS in Science/Engineering

Experience

  • For Associates/Bachelors: 1-4 years of experience in biopharmaceutical/pharmaceutical industry.

  • For Masters: 0+ years of experience in biopharmaceutical/pharmaceutical industry.

*Applicants must be open to working a 12 hour, night shift schedule (6pm-6am). Will include weekend hours.

Desirable Requirements

Knowledge

You will have an understanding of basic scientific principles. You will have an understanding of basic biotech manufacturing processes. You wil have a good understanding of cGMPs, Regulatory standards and concepts.

Problem Solving

You will develop solutions to compliance problems of moderate scope and complexity.

Freedom to Act

You will work with increased independence under general supervision. Your work will require the exercise of discretion and judgment and interpretation of established procedures. Your work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

Impact

You will ensures compliance to cGMPs and identifies potential compliance risks. You will contribute to the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources. You will have the ability to release solutions, process intermediates and raw materials for further manufacturing use.

Interpersonal Communication

Your contacts are primarily with department peers, supervisor and cross-functionally with supervisors and technicians. Infrequent outside customer contacts on routine matters. You will have excellent communication and interpersonal skills. You will have excellent technical writing skills.

Supervisory/Management Skills

No direct supervisory role. You will have the aility to provide guidance to peers and personnel from other functional areas.

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.