Sr. QA Specialist/Manager/Sr. Manager - Gaithersburg, MD | Biospace
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Sr. QA Specialist/Manager/Sr. Manager

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
9/24/2017
Position Type:
Full time
Job Code:
R-012384
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-012384
Posted date: Aug. 14, 2017

Sr. Quality Specialist/Manager/Sr. Manager

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 Sr. Quality Specialist/Manager 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.

Position Summary

Responsibilities and experience may include the following: Operational Excellence and/or ASQ certifications. Change management.  Risk based management. Project management tools. Process flow diagram and process map. Supports the evaluation and lifecycle of all aspects of change management. Investigates and assesses the impact to deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems.  Identifies root causes and recommends/implements corrective actions to prevent recurrence. Performs trend analysis to monitor quality system performance.  May travel frequently. Represent company at vendor locations.

Principal Duties

Responsible for Quality functions for External Suppliers Quality Assurance. 

The Senior Quality Specialist supports functions that impact Manufacturing, Facilities, Validation, Quality Control and Quality Assurance at External sites. 

Implements quality policies, oversees change management and assists in facilitating regulatory compliance inspections.

Participating in Corporate supplier audit program.

Utilizes Operational Excellence (Six Sigma) tools in assessing quality systems.

Drives efficiency initiatives in Quality.

Additional Job Functions:

Assists Associate Director in management of compliance and quality processes for External Quality Department.

Manages Databases and Metrics for Department.

Operates in supplier qualification and monitoring area for both CMOs and Raw Materials.

Ensures and demonstrates suppliers are fully qualified per process.

Performs new CMO QAA drafting, negotiation and closure.

Revises and amends QAAs as needed.

Review and approval of Supplier Initiated Changes per process.

Review and approval of Product Complaints per process

Monitors External Quality mailbox to ensure shareholder concerns are addressed.

First point of contact for quality issues escalation with CMO and RM manufacturers.

Investigates and assesses the impact of deviations that may occur during external manufacture, testing or distribution of products.

Works within the framework of the QAA to push CMO NCs, OOS, OOT to closure.

Develops MRB presentation slides for assessment by shareholders.

Works to build relationships with CMOs.

Performs risk assessments of suppliers.

Ensures risk assessment plans are performed.

Conducts quarterly meeting with manager on status of oversight of suppliers.

Conducts monthly External Quality meeting with manager and group to present current state of department (metrics, status of qualifications, status of QAAs)

Participates in the development of new systems/processes to improve the External Quality Department.

Responsible for ensuring that Development and Operations for external manufacturing and testing processes meet current GMP requirements.

Qualifications

B.S. Technical Field.  At least 5 years of experience in a pharmaceutical related industry.  Preferably with hands on operational experience.

*LI-MEDI

~BSP

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.

Requirements

Please See Description