Day Shift QA Specialist I/II – GMP Quality & Compliance

CSL Plasma; Holly Springs (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Onsite café

Walking trail

Basketball and tennis courts

Medical insurance

Dental insurance

Vision insurance

Life Insurance

401K with 6% match

Annual bonus

PTO

Wellness days

Floating holidays

Job summary

Seqirus in Holly Springs, NC is seeking a QA Specialist (Day) to oversee on-floor quality for manufacturing, laboratories, utilities, maintenance and logistics. You will ensure cGMP compliance and support site quality programs.

You will perform real-time batch record reviews, conduct quality walkthroughs, and participate in deviations and investigations. On-site benefits and a 6% 401K match are included as part of Seqirus’ benefits package.

Qualifications

• Bachelor's degree in Science or Engineering preferred or equivalent biotech/pharma experience.
• Experience in GMP fermentation, purification, sterile formulation, filling or packaging operations in pharma/biotech.
• Experience in a FDA-regulated manufacturing or laboratory quality role.
• Demonstrate risk-based decision making.
• Experience leading complex projects or teams.

Responsibilities

• Perform real-time batch record/logbook review concurrent with manufacturing operations on the 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.

Skills

Quality oversight

cGMP

Auditing

Root cause analysis

Project leadership

Risk-based decision making

Education

Bachelor's degree in Science/Engineering

Tools

Veeva

SAP

LIMS

Job description

Seqirus in Holly Springs, NC is seeking a QA Specialist (Day) to oversee on-floor quality for manufacturing, laboratories, utilities, maintenance and logistics. You will ensure cGMP compliance and support site quality programs.

You will perform real-time batch record reviews, conduct quality walkthroughs, and participate in deviations and investigations. On-site benefits and a 6% 401K match are included as part of Seqirus’ benefits package.