Senior Product Specialist

Job Description

Senior Specialist, Quality Technical (P3)

The Senior Specialist Quality Technical role is responsible for supporting deviation management, change control, site qualification/validation, equipment qualification, and technical quality support for sterile manufacturing of vaccines. The ideal candidate would have knowledge of the referenced areas of responsibility as well as a thorough understanding of sterile manufacturing and background working with grade A,B, C and D area including isolator operation.

Primary Responsibilities:

The Quality Senior Specialist will be responsible for providing quality oversight and technical guidance of sterile vaccine manufacturing activities across the Durham VMF IPT.  Areas of responsibility will include the following:

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

• Contributes to the performance and results of the daily manufacturing activities.

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

• Provides quality oversight and technical guidance to employees, colleagues, or clients.

• 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), Corrective/Preventative Actions (CAPAs) and Change Requests (CRs). 

• Author, review, and approve SOPs.

• Review and approve BOM changes and Master Batch Records.

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

• 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.

• 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.

• 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.

• Provides support for technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units.

• 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.

• Other duties as requested by Management.

Minimum Education Requirement and Experience:

• Bachelor’s degree (BA/BS) in Biology, Biochemistry, Chemistry, or other relevant discipline with a minimum of five (5) years' experience supporting the pharmaceutical manufacturing industry, specifically in pharmaceutical operations, technical operations, validation and/or process Quality Assurance.

Required Experience and Skills:

• Previous investigation and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control.

• Has in-depth knowledge of cGMPs and domestic and international regulatory requirements. 

• Is expected to possess a high degree of problem-solving ability.

• Must have demonstrated ability to independently manage multiple high level/ priority projects, ensuring timely completion.

Preferred Experience and Skills:

• Quality Technical experience

• Electronic Batch Records (MES)

• cGMP experience in a sterile, bulk or finished pharmaceutical environment

• Product, Raw Materials and Components Release

• Experience with SAP or MRP/ERP systems

• Experience with SAP, or GLIMS

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