QA Specialist IV - (Gaithersburg, MD)
If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a QA Specialist IV in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
Responsibilities and experience may include the following: Quality at the source utilizing on the floor real time review of batch records and addressing product quality issues and possible non-conformances as they occur. Auditing (internal and external - utilizing risk based strategy. Document systems. Change management utilizing a risk based approach. Operational Excellence utilizing tools such as DMAIC and root cause analysis. Electronic system utilizing tools such as Trackwise and SAP. Contribute to product release utilizing systematic process flows. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections. Assist QA management to develop the department budget and analyze headcount requirements. May travel internationally and represent company during audits.
Complete understanding and wide application of technical principles, theories and concepts in the areas of clinical manufacture of biologics. To include process development methodology, analytical methods, technology transfer, and CMC Processes. General knowledge of other related disciplines.
Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable and consistent with organizational objectives.
Discretion / Latitude:
Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy, in meeting objectives.
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.
Inter-organizational and outside customer contact.
- Responsible for auditing internal and external-utilizing a risk based strategy. Change management utilizing a risk based strategy.
- Operational excellence utilizing tools such as FMEA, DMAIC and root cause analysis.
- Quality at the source utilizing on the floor real time review and investigations. The QA Specialist supports and provides advice to a number of functional areas including manufacturing, facilities, IT and other Quality departments.
- Interprets and implements quality procedures, manages quality systems and assists in facilitating regulatory compliance inspections.
- Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval.
- Assists the QA Manager to develop the department budget and analyze headcount requirements. May supervise the activities of other QA Specialists.
- Utilizes quality assurance system in compliance with current good manufacturing practice regulations.
- Administers the change control and Deviation and corrective action systems for assigned products and quality systems.
- Maintains database, generates standard and ad hoc reports.
- Manages workflow to assure timely supply of commercial product.
- Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.
- Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems.
- Identifies root cause, recommends and implements corrective actions to prevent recurrence.
- Performs trend analysis to monitor process and facility performance.
- Employs metrics to track the performance of operations and quality systems.
- Reviews validation protocols and summary reports.
- Support other groups on completion of annual review and annual product reports.
- Performs in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.
B.S. in Biology, Chemistry, Engineering or related fields. Specialist position based on education.
7+ years experience
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Outlook, Deviation, CR Tracking Software, EDMS, Explorer, Excel, Word, MS Office
More about the Gaithersburg site
Some 2nd shift work may be required as per departmental need to support the manufacturing 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