Apply on Employer Site

CSL · 2 days ago

FLQA Specialist

Seqirus USA - NC - Holly Springs

Full-time

Onsite

Mid Level

3+ years exp

CSL Seqirus is a leading provider of influenza vaccines, dedicated to protecting communities from seasonal influenza and global pandemic threats. The FLQA Specialist will apply quality principles related to equipment qualification and validation, ensuring compliance with cGMP and regulatory requirements while providing technical support and oversight in various operational areas.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

Ensure that qualification, validation, and technical protocols, and reports comply with site SOPs. Provide review and approval of related documents

Provide QA oversight to equipment qualification, technical transfers, process, method, cleaning and computer system validation including revalidation and re-evaluation

Maintain audit program, reviewing functional and release documentation, and reviewing and approving deviation investigations relevant to area(s) of responsibility

Review lot release documentation and Facilitate compliant release process for corresponding market

Respond to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release

Ensure standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements

Interface with customers and partners on quality related issues

Execute training/awareness related to GMP standards

Provide training on quality concepts and tools