Specialist, Quality Control

Job Description

Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

GENERAL SUMMARY:

Our Company is expanding its global vaccine production by adding an end-to-end laboratory capability located in the Durham, NC campus. The facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for vaccine.

The Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing for product. Initially the position will focus on microbiology and sterility testing readiness in preparation for commercial production.  The selected candidate will participate in assay development, assay validation, equipment validation, and GMP laboratory readiness.  The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples, including bulk vaccine, filled vaccine, and media. The successful candidate will support the microbiology testing laboratories with emphasis on microbiological methods such as microbial enumeration, bacterial endotoxin (of support systems), and sterility (of in-process materials and finished product). The selected candidate will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong understanding of Labware Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support.

GENERAL PROFILE:

• Collaborate with internal customers and vendors to identify, evaluate, and implement new analytical technologies that expand site capabilities.  Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.

• Build knowledge of the company, processes, and internal/external customers

• Build and maintain strong relationships with site leadership, stakeholders, and customers

• Build relationships to work in a highly functioning diverse team environment

• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals

• Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing

• Capability to function effectively within an automated/electronic laboratory environment

• This position will be located at the Durham, NC site. 

• Occasional overtime and weekend support maybe required based on business needs.
   

BUSINESS EXPERTISE:

• Understands the fundamental business drivers for the company; uses this knowledge in own work

• Understands and applies regulatory/ compliance requirements relative to their role

• Influence, motivate, and energize individuals at all levels in the organization

FUNCTIONAL EXPERTISE:

The Quality Operations Laboratory Specialist will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include the following:

• Microbiology and sterility assay qualification, including but not limited to microbial enumeration testing, endotoxin, rapid microbiology methods, compendial sterility testing and non-compendial sterility testing.

• Microbiology and sterility routine testing, including but not limited to microbial limits, endotoxin, rapid microbiology methods, compendial sterility testing and non-compendial sterility testing.

• Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods

• Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Corrective/Preventative Actions

• Execute test method qualification

• Trouble-shoot equipment issues as needed

• Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures

• Laboratory maintenance including managing stock of reagents,