Position Summary :
This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in-process and stability test data.
This position is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigation and deviations associated with the laboratories.
Position Responsibilities :
Performs compliance review on the following records : release, in-process, and stability data
Responsible for the review and approval of method qualifications and validations
Responsible for the review and approval of deviations and laboratory investigations
Minimum Requirements :
For Specialist II : BS and 11+ years of experience or MS and 8+ years of experience in a GMP regulated environment within biopharmaceuticals or equivalent
For Senior Specialist : BS and 14+ years of experience or MS and 11+ years of experience in a GMP regulated environment within biopharmaceuticals or equivalent
Experience in QA review of analytical data (release, in-process, and stability)
Experience in reviewing method qualifications / validations and the review and approval of laboratory investigations and deviations
Knowledge of USP, EU and JP cGMP guidelines
QA Specialist II - Deviations & CAPAs
Support Manufacturing QA departmental responsibilities to include review of batch records and/or raw materials release as needed. Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timel...
Senior Emergency Communications Specialist
Senior Emergency Communications Specialist. As an emergency communications specialist, you will play a key role in the operation and success of the emergency services program, protecting Wolfspeed’s people, property, and processes through support of our global emergency services and security teams. ...
Field Claims Specialist II, National Catastrophe Property - Personal Lines (North Carolina/Virginia)
As a National Catastrophe (NATCAT) Field Claims Specialist primarily supporting our Personal Lines (PL) business, you'll investigate and resolve moderate to severe property damage claims by phone. ...
Senior Specialist, Regulatory
Responsible for regulatory compliance as it relates to contract manufacturing and analytical services.Responsible for the coordination and evaluation of regulatory activities.Perform various activities for CMC authoring and review in support of client filings.Consult with clients on regulatory topic...
Senior Technical Writer/Documentation Specialist
As a Senior Technical Writer/Documentation Specialist specializing in systems integration, you will play a crucial role in creating and maintaining comprehensive technical documentation for our in-store retail media platforms. Proven experience in technical writing or documentation specialist role, ...
Proposals & Contracts Specialist II
Proposals and Contracts Specialist II (P&C Specialist II). Under the direction of management or an experienced Proposals lead, the Proposals & Contracts (“P&C”) Specialist is responsible for the development of proposals and contracts for new and existing business, in consultation with the Sales Team...
Senior Employment Specialist
The Senior Employment Specialist leads World Relief Durham’s (WRD) job placement services for newly arrived and ORR eligible refugees in the Triangle region of North Carolina, through the Matching Grant (MG) and Refugee Support Services (RSS) programs. The Senior Specialist cultivates and maintains ...
Corporate Leave Specialist II - Benefits
CORPORATE LEAVE SPECIALIST II – BENEFITS. THE CORPORATE LEAVE SPECIALIST II - BENEFITS WILL. REQUIREMENTS FOR THE CORPORATE LEAVE SPECIALIST II - BENEFITS. ...
ITPRONCBMWeb Content Specialist- Senior
NC CoR Web Content Specialist Senior (748790). ...
Senior Tax Specialist
SymphonyAI is looking for a Senior Tax Specialist who will report to the VP – Global Tax. Tax Specialist to join our team! At SymphonyAI, we are building the leading AI SaaS company for enterprise transformation across the most critical industry sectors. Communication and Collaboration: • Collaborat...