Specialist I, QA

CSL•Holly Springs, NC

1d•Onsite

About The Position

Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day. The QA Specialist will be reporting to the QA Supervisor. You will work onsite at our CSL Seqirus in Holly Springs, NC location. You will be responsible for direct, on the floor, quality oversight of Seqirus Holly Springs' manufacturing, laboratories, utilities, maintenance, and logistics. You will provide strategic and technical support for the site's cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements.

Requirements

Experience in a GMP fermentation, purification, sterile formulation, sterile filling, or packaging operation with technical knowledge of the production processes used in the pharmaceutical or biotechnology industry
Experience in quality role in an FDA regulated manufacturing or laboratory setting or an understanding of the quality requirements for the pharmaceutical industry
Demonstrate risk-based decision making
Experience leading complex projects or teams
Experience in root cause analysis, including working experience of root cause analysis tools such as fishbone/5Why

Nice To Haves

Bachelor’s degree in Science/ Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry

Responsibilities

Perform real-time batch record/logbook review concurrent with manufacturing operations on the manufacturing floor
Perform routine quality walkthroughs and audits in manufacturing and controlled spaces
Support quality systems related to QA for in-process sampling and controls
Be a quality representative on the floor during manufacturing operations and troubleshooting. Escalate potential product or process related issues as needed.
Provide quality oversight of site critical alarm reports and corrective maintenance program
Support the development and revision of SOPs and batch records
Perform activities related to change controls, writing deviations and investigations, and using electronic enterprise systems – Veeva, SAP, LIMS, etc.
Apply knowledge of regulatory requirements for pharmaceutical, biotech and vaccine industries.
Participate in external and internal audits and represent the Quality function