Quality Sr. Specialist
MSDAbout the role
Job Description
The Quality Senior Specialist provides expertise pertaining to qualification/validation activities supporting a vaccine expansion facility at West Point, PA. The role will support various initiatives as the B63A Syringe Filling Facility capital project progresses through various stages including Process Qualification (PQ), Tech Transfer, Process Performance Qualification (PPQ), licensure into commercial manufacturing.
Primary Responsibilities:
The Quality Senior Specialist will be responsible for comprehensive management of all activities required to successfully support facility startup and routine manufacturing to include:
Assume project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management.
Direct support of regulatory inspections and audits.
Direct support of validation activities, including review and approve qualification/validation documents for equipment and process.
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.
Participate in Quality Risk Management activities.
Review and approve technical protocols (ex. Development studies).
Provides input, direction, and approval of Quality Notifications (QNs) and Change Requests (CRs).
Author, review, and approve SOPs.
Develop batch disposition process for IPT.
Other duties as requested by Management.
Minimum Education Requirements and Experience:
Bachelor’s degree (BS) in a science or engineering discipline, or other relevant degree. A minimum of five (5) years' experience supporting the pharmaceutical manufacturing industry, specifically in pharmaceutical Quality, Operations, Technical Operations and/or Validation.
Required Experience and Skills:
Ability to work independently and as a member of a team.
Previous experience with investigation and CAPA, Validation and Change Control processes.
Has in-depth knowledge of cGMPs including domestic and international regulatory requirements.
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:
cGMP experience in a sterile, bulk or finished pharmaceutical environment.
Drug Substance, Drug Product or Raw Material / Component Release.
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Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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