Senior Specialist, QA (Hybrid)

Job Description

Senior Specialist, Quality Systems and Compliance (P3)

Our company is expanding its global recombinant vaccine production network by investing and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps. 

The Quality Senior Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities supporting the vaccine expansion facility.

Primary Responsibilities:

The Quality Senior Specialist will be responsible for comprehensive management of all activities required to successfully support Process Performance Qualification (PPQ) and routine manufacturing to include the following:

• Ability to work independently and as a member of a team.

• Manages individual contributors (professional employees), as applicable.

• Contributes to the performance and results of the expansion project.

• Adapts plans and priorities to address resource and operational challenges.

• Decisions are guided by policies, procedures and/or business plans.

• Provides technical guidance to employees, colleagues, or clients.

• Anticipates and interprets client and/or customer needs to identify solutions.

• Ability to provide off shift and weekend support during critical processing and manufacturing.

• Responsible for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures. 

• Responsible for establishing processes that ensure required safety guidelines are followed. 

• Review and approve qualification/validation documents for equipment and process (i.e., IQ/OQ/PQ).

• Review and approve Performance Qualification documents pertaining to environmental monitoring and process qualification.

• Provides Quality input, direction, and approval of Quality Notifications (QNs) and Change Requests (CRs).  Author, review, and approve SOPs.

• Assume project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management.

• Train employees on new or revised processes or procedures.

• Review and approve BOM changes and Master Batch Records.

• Review and approve Operations, Technology, or Automation protocols.

• Leads or actively participates in project suite teams, as required.

• Direct support of regulatory inspections and audits.

• Direct support of validation activities and all other associated Quality functions.

• Other duties as requested by Management.

• Independently supports resolution of technical and operational problems through collaboration with peers. 

• Applies appropriate risk management while adhering to cGMP requirements.

• Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.

• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.

Minimum Education Requirement