Specialist II/III, QA at CSL in Holly Springs, NC

Reporting to the Front-Line Quality Assurance (FLQA) Senior Manager, the QA Specialist is an individual contributor providing strategic and technical support for the Quality Control, FacOps, and Warehouse departments at the Holly Springs site in all cGMP compliance related matters to ensure all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements. This position is for a FLQA Specialist role working Monday-Friday during core business hours. Candidate must be flexible in their schedule to support the business and the seasonal needs of influenza vaccine production. Job details are below:

Ensure the completion and compliance of the following activities:

• Deviation reports which are technically sound and include robust investigation,

identification of root cause, development and execution of strong and robust CAPAs and

Effectiveness Checks.

• Change controls which are technically accurate and comprehensive in scope including

assessment of risk.

• Routine QA walkthroughs and process audits.

• Protocol, test plan and other GMP document QA approvals including validation deliverables

in Quality Control, FacOps, and Warehouse collaborating with CQV (Commissioning

Qualification and Validation), MS&T (Manufacturing Science and Technology), AS&T

(Analytical Science and Technology), and Engineering.

Responsible for the use of Quality Management Systems for cGMP areas in the facility, such as

Deviation/CAPA management, Change Management, document management training systems,

etc. • Ensure compliant use of Quality Systems and achievement of key performance indicators.

• Assess criticality of deviations and change controls.

• In response to deviations/change controls, drives appropriate product quality impact

assessments, corrective actions, implementation actions, and batch control activities.

• Ensure all minor and major quality issues in their areas are appropriately investigated and

CAPAs created to prevent recurrence.

• Drives adherence to and continuous improvement of the quality systems through

identification of trends or non-conformances.

• Confirms as applicable that activities in Quality Control, FacOps, Warehouse, CQV

(Commissioning Qualification and Validation), MS&T (Manufacturing Science and

Technology), AS&T (Analytical Science and Technology), and Engineering are compliant

with GxP and/or Seqirus procedural requirements and that data integrity is maintained on

an ongoing basis.

• Responsible for the development of Quality Systems in area of oversight. Responsible for

the development and implementation of standard operating procedures (SOPs) and

supplemental documents governing management and usage of each quality system of

responsibility.

• Reviews documentation for compliance, completeness and data integrity.

• Performs data verification checks as needed for data obtained from area of oversight

being provided to regulatory authorities (e.g., approving data included in source

documents, regulatory filings or communications with health authorities).

• Actively participates in self-inspections for Quality Control, FacOps, and Warehouse and

drives resolution to audit findings.

• Ensures compliance with Seqirus’ quality, compliance, safety, GMP and regulatory

standards at all times.

• Ensures on-time completion of all assigned training.

Serves as a Quality Assurance partner to Quality Control, FacOps, and Warehouse departments.

• Acts as the primary QA support of Quality Control, FacOps, and Warehouse, including on-

the-floor support and the issue triage and escalation process.

• Applies advanced technical and quality knowledge to support risk-based decision making

on any key topics or issues.

• Provides on the floor coaching to staff to embed a quality mindset, build compliance and

quality knowledge and sustain strong quality culture.

• Advises Quality Control, FacOps, and Warehouse departments on applicable requirements,

deferring to more senior members in QA for complex issues.

• Acquires and maintains knowledge of Seqirus manufacturing process, SOPs and Policies,

regulatory requirements and guidance (e.g., Good Laboratory Practice, Good

Manufacturing Practice, Quality by Design), to ensure that sound advice and appropriate

QA technical support on all quality/compliance-related matters are provided to Quality

Control, FacOps, and Warehouse departments at the site level for relevant markets.

• Ensures inspection readiness via performing routine quality walkthroughs, monitoring

quality system adherence, and direct involvement in Site Self Inspections.

• Generate deviation and change control sub-reports in support of Annual Product Quality

Review.

Candidates may be considered at level I, II or III depending on experience.

Educational Requirements:

Bachelor’s degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.)

Experience Requirements:

•1-5+ years' GMP experience in pharmaceutical/biotech or other regulated industry (According to the hiring Level)

• Strong decision-making skills required • Knowledge of current Good Manufacturing Practices (cGMP) principles • Knowledge of FDA and EMA requirements

•Knowledge of similar analytical process is preferred • Previous work in a laboratory (in vitro and/or animal studies) in a QC, Research, Development, Manufacturing or Quality role required.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus