1-3 years Sample Plan experience in a GMP environment is required; biotech/pharma/biologics is highly preferred.
Quick Overview:
The Sr. Specialist 2, QC Program Management Technical Transfer (TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 2, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in and leads collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports GMP compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.
Summary:
Collaborates with customers and stakeholders from QC and DS Manufacturing (DSM) to support tech transfers of new customer projects as they relate to QC Sample Plans and DS/DP Specifications.
Authors, reviews, and leads updates of controlled GMP documents related to QC Sample Plans and QC Specifications.
Leads, authors, and reviews change controls of QC Sample Plans for both internal and external changes together with relevant stakeholders, including communication with customers as applicable.
Manages and directs the continuous improvement of QC Sample Plans and QC Specifications.
Applies holistic quality system approach through identifying and solving technical and compliance gaps and areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation.
Leads and participates in team compliance activities including writing, changing, and maintaining GMP documents in collaboration with relevant stakeholders and QA.
Ensures compliance with platform, procedures, and global QC vision.
Supports management in training compliance with policies and inspections.
Supports regulatory requests, audits, and inspections.
Collaborates with the LIMS team and IT department to build DS/DP sample plan and specification functions that meet end-user and customer requirements.
Provides guidance and feedback for QC personnel development.
Performs other duties, as assigned
Minimum Requirements
Bachelors in Biological Sciences, Engineering, or related science field with 5+ years of relevant experience OR
Masters in Biological Sciences, Engineering, or related science field with 3+ years of relevant experience
Prior experience of project management experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)
1-3 years' experience in a GMP environment
Prior experience in leading technical writing initiatives.
Preferred Requirements
Experience with Customer Relationship Management
Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.
Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)
Prior experience in leading project improvement management.