Specialist I /II / III, QA

CSL • Holly Springs, NC

2d • Onsite

About The Position

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

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

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

Benefits

• Onsite Café
• 1/2 mile Walking Trail
• Basketball and Tennis Courts
• Medical Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• 401K with a 6% match
• Annual bonus
• Accrued PTO
• Wellness days
• Floating holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level