QA Specialist (Nights) Position Available In Wake, North Carolina

QA Specialist (Nights)
Employer
CSL
Location
Holly Springs, NC
Start date
May 16, 2025
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Company
Job Details Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? 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. Our benefits include an Onsite Café, 1/2 mile Walking Trail, Basketball and Tennis Courts; access to Medical, Dental, Vision, Life Insurance, 401K with a 6% match and an annual bonus; and accrued PTO, wellness days and floating holidays.

Shift:

Night

Hours:

6 PM- 6PM
Follow 2-2-3 schedule
Job level will be determined based on years of relevant experience to our processes and equipment 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 Experience 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 #LI-Onsite Our Benefits CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee. About CSL Seqirus CSL Seqirus is part of CSL Limited (

ASX:

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. Learn more about CSL Seqirus. We want CSL Seqirus to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL. Do work that matters at CSL Seqirus! Watch our ‘On the Front Line’ video to learn more about CSL Seqirus Company CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Areas of Expertise We focus and demonstrate global leadership in three distinct areas—rare and serious diseases; influenza vaccines; and iron deficiency and nephrology. Rare & Serious Diseases CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Vaccines 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. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries. Iron Deficiency & Nephrology With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women’s health, we help patients affected by these conditions to live better, healthier lives. Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States