AstraZeneca Pharmaceuticals LP QA Specialist IV - ATS - Global Biologics Operations 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.
Responsible for assuring the quality of commercial and clinical products manufactured at the facility.
Supports functional areas including manufacturing, facilities and other Quality departments.
Implements quality policies for process improvements.
Change management utilizing a risk based approach.
Electronic system usage with tools such as PAS-X, Trackwise and SAP.
Ability to learn the use of Operational Excellence tools such as Lean, Six Sigma, DMAIC and root cause analysis.
Ability to communicate and work effectively with internal customers.
Demonstrated technical ability and skills in assigned work area to include product, process and/or testing knowledge.
Ability to review and understand analytical data. Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers.
Author documents, and participate in change review of SOPs.
Employs metrics to track performance of Operations and Quality Systems.
Assist in the management of identified projects impacting the department.
In addition to the above, a Quality Specialist IV would also perform:
Supports the evaluation and lot disposition of intermediates and finished bulk drug substance through timely review of batch records, laboratory results and other GMP documents.
Performs on the floor inspections of the production areas to resolve issues early and to ensure compliance with SOP and regulatory requirements.
Identifies and assesses the impact of minor and major risk deviations that may occur during manufacture.
Performs preliminary risk assessment of deviation records and assigns criticality levels, including as applicable, identification of root causes and establishment of corrective actions. Provides Quality Assurance Approval of devaitions.
Reviews, assess and approves change controls, deviations and corrective actions.
Acts as back-up for other Qualiy Units in off-hours. Re-issues batch record pages; issues logbook pages, SPRs and MPRs.
On the Floor SPR/MPR and autoclave review.
PCS alarm review.
Assist in product changeover, zone promotions, placing QA hold tags, logbook extensions.
Performs Return to Service of areas and equipment.
Routinely provides compliance guidance to Manufacturing team.
Review and disposition process intermediates in SAP.
Serves as a QA-ATS representative for project teams.
Uses data to help drive quality improvement in documentation practices and production related activities.
Assists in facilitating regulatory compliance inspections.
- Good understanding of basic scientific principles. Understanding of basic biotech manufacturing processes. Good understanding of cGMPs, Regulatory standards and concepts. General knowledge of other related disciplines.
- Provides technical solutions to a wide range of complex problems. Solutions are imaginative, thorough, practicable, and consistent with organizational objectives.
Freedom to Act
- Works independently with only minimal direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
Ensures compliance to cGMPs and identifies potential compliance risks.
Contributes to the completion of specific programs and projects.
Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Ability to release solutions, process intermediates and raw materials for further manufacturing use.
Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects. Provides direction and guidance to other team members.
Excellent written and oral communication skills.
Excellent collaboration skills, with focus on customer service
Experience leading and working effectively with cross-functional teams with representatives from various departments and levels.
- Leads, oversees complex projects and programs, interdepartmental and corporate goals. Externally recognized and consulted strategist. Provides training to new employees. Assists in the supervision of activities of other QA Specialists.
Change Management and Collaboration
Develops and designs change initiatives; evaluates corporate business processes and proposes improvements.
Leads strategic planning where impact is interdepartmental or corporate.
Effectively drives solutions and improvements for complex, critical cross-functional and corporate projects.
Bachelor's Degree with minimum 7 years of biotech/pharmaceutical industry experience.
Master’s Degree with minimum 3 years’ experience in biotech/pharmaceutical Quality Assurance.
Science (e.g. Biology, Chemistry) or Engineering (e.g. Biochemical, Chemical, Mechanical) Degree Preferred
Minimum 5 years’ experience in Quality Assurance.
Experience working in a highly regulated environment (FDA, EMA)
This position is night shift on a 2-2-3 rotating schedule
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.