Current jobs related to Senior Specialist, R&D FLQA - Holly Springs - CSL Seqirus
-
Holly Springs, United States CSL Seqirus Full timeDo 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...
-
Holly Springs, United States CSL Seqirus Full timeDo 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...
-
Holly Springs, NC, United States CSL Seqirus Full timeDo 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...
-
Quality Assurance Specialist
3 weeks ago
Holly Springs, Georgia, United States R&D Partners Full timeJob Title: Quality Assurance SpecialistAt R&D Partners, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products and services.Key Responsibilities:Lead deviation investigations to identify root cause and implement...
-
Holly Springs, United States CSL Seqirus Full timeAt CSL Seqirus, we're committed to protecting communities from seasonal influenza and global pandemic threats. As the Senior Manager of the 24/7 FLQA Team, you'll play a critical role in ensuring the highest standards of quality, housekeeping, and safety are applied within all GMP areas across the Holly Springs site.Key Responsibilities:Provide technical...
-
Quality Assurance Specialist
1 week ago
Mount Holly Springs, Pennsylvania, United States R&D Partners Full timeJob SummaryAs a Quality System Specialist at R&D Partners, you will play a critical role in ensuring the quality and integrity of our clients' products and services.Your key responsibilities will include:Leading deviation investigations to identify root causes and implement corrective actionsInitiating and performing EDMS workflowsCompleting change control,...
-
Quality Assurance Specialist
1 week ago
Mount Holly Springs, Pennsylvania, United States R&D Partners Full timeJob SummaryR&D Partners is seeking a Quality Assurance Specialist to join our team. In this role, you will be responsible for leading deviation investigations to identify root causes and implementing corrective and preventative actions to prevent reoccurrence. You will also initiate and perform EDMS workflows, complete change control, self-inspection, and...
-
QA Specialist
1 week ago
Holly Springs, United States CSL Seqirus Full timeDo 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...
-
QA Specialist
1 week ago
Holly Springs, United States CSL Seqirus Full timeDo 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...
-
QA Specialist
1 week ago
Holly Springs, United States CSL Seqirus Full timeDo 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...
-
QA Specialist
1 week ago
Holly Springs, United States CSL Seqirus Full timeDo 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...
-
R&D Specialist
2 weeks ago
Colorado Springs, Colorado, United States Stageco U.S., Inc. Full timeJob Title: R&D TechnicianJob Summary:We are seeking a highly skilled R&D Technician to join our team at Stageco U.S., Inc. The successful candidate will be responsible for creating preliminary drawings, revising drawings, and implementing changes as instructed by project managers. They will also be responsible for delivering drawings to structural engineers,...
-
Quality Assurance Specialist
4 weeks ago
Holly Springs, NC, USA, United States PharmEng Technology Americas Full timeJob OverviewPharmEng Technology Americas is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.The ideal candidate will have a strong background in GMP regulations and experience in a...
-
R&D Innovation Specialist
4 weeks ago
Altamonte Springs, Florida, United States Inteletech Global Inc. Full timeR&D Engineer Job DescriptionWe are seeking a highly skilled R&D Engineer to join our team at Inteletech Global Inc. As a key member of our research and development team, you will be responsible for leading the development of new products and processes, focusing on plastics manufacturing, including extrusion, thermoforming, and tooling.Key...
-
R&D Specialist
6 days ago
Colorado Springs, Colorado, United States STAGECO US INC Full timeAbout STAGECO US INCWe are a leading international staging company with over 40 years of experience in designing and building custom-made and standardized concert stages and temporary structures for various events.Our team is committed to achieving the highest levels of engineering excellence, and we are looking for a skilled R&D Technician to join our...
-
R&D Process Integration Specialist
1 month ago
Colorado Springs, Colorado, United States Advanced Technology Search Full timeR&D Process Integration EngineerOur client, a leading manufacturer of Mobile RF Front End ICs, Filters, and Modules, is seeking an R&D Process Integration Engineer to join their team at Advanced Technology Search.The ideal candidate will have hands-on experience in cleanroom and characterization lab work, as well as strong knowledge of semiconductor or MEMS...
-
R&D Innovation Specialist
4 weeks ago
Altamonte Springs, Florida, United States Inteletech Global Inc. Full timeAbout the RoleWe are seeking a highly skilled R&D Engineer to join our team at Inteletech Global Inc. As a key member of our innovation team, you will be responsible for leading the development of new products and processes, focusing on plastics manufacturing, including extrusion, thermoforming, and tooling.Key ResponsibilitiesDesign, prototype, and test new...
-
R&D Technician
1 week ago
Colorado Springs, United States STAGECO US INC Full timeAbout Stageco Born out of supplying stages for the renowned Rock Werchter Festival in Belgium in 1985, Stageco is now one of the world's most prominent international staging companies. Through more than 40 years of experience, Stageco has become the worldwide pioneer and trendsetter in designing and building custom-made and standardized concert stages and...
-
Senior Billing Specialist
1 month ago
Bonita Springs, Florida, United States Discovery Senior Living Full timeJob Title: Billing SpecialistAt Discovery Senior Living, we are seeking a skilled Billing Specialist to join our home office team in Bonita Springs, FL.Job Summary:This position will be responsible for processing resident billing for Discovery Senior Living managed communities. The successful candidate will be responsible for generating resident billing in a...
-
Medical Care Specialist
2 days ago
Colorado Springs, Colorado, United States D&Y Full timeMedical Care SpecialistRequirementsAs a Medical Care Specialist with D&Y, you will provide high-quality patient care in a dynamic and fast-paced environment. Your responsibilities will include managing patient caseloads, conducting thorough assessments, and developing effective treatment plans. You will work closely with our team to ensure seamless care...
Senior Specialist, R&D FLQA
3 months ago
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.
This position in R&D QA reports to the Associate Director, Quality and will provide Front Line QA oversight of bulk and fill finish manufacturing activities for clinical trial material produced in Small Scale Filling onsite in our Holly Springs, NC facility and related changes and deviations. Benefits Include flexible hours M-F, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from first day of hire.
Responsibilities
- Perform real time batch record/logbook/document review concurrent with manufacturing on the floor and review executed batch records and development/validation/qualification protocols
- Perform routine quality walkthroughs of site GMP facilities and operations
- Be a quality representative on the floor during troubleshooting and issue resolution. Escalate potential product or process related issues as needed.
- Provide quality oversight of SSF critical alarm reports and corrective maintenance program, and area's quality systems and compliance
- Use of computerized systems such as: SAP, TrackWise, GLIMS, and BAS
- Support greater R&D FLQA organization including quality approval of deviations and/or change controls, quality support of suite teams, and quality representation on site projects.
- Responsible for knowledge of current local and international regulatory requirements ● Provide advice and appropriate technical support on all quality/compliance matters Additional Accountabilities:
- Ensure bulk and semifinished material for clinical batches comply with applicable Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) requirements, current clinical trial protocol registered with the applicable health authority and phase-appropriate cGMP.
- Support the development of batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, development/validation/qualification protocols and reports etc. to comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.
- Ensure data integrity and by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness.
- Author phase appropriate FLQA procedures for oversight of clinical manufacturing activities
- Provide QA oversight on the shop floor to the manufacture and distribution of products for clinical trials in Holly Springs, including sterile manufacturing and liasing with TD, Operations, QC, sterility assurance etc. as required.
- Implement the quality strategy for phase-appropriate manufacturing of clinical trial material, which may be either internal or outsourced to Contract Manufacturing Organizations, and identified areas for continuous improvement Establishes relationships with R&D QA and other global Quality functions:
- Advise R&D on applicable requirements, partnering with more senior members in R&D QA for complex issues
- Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets
- Identify and escalate risks to compliance to senior management
- Provide QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities
- Support internal audits and helps prepare for regulatory inspections, inspection finding responses related to applicable area of oversight and the provision of accurate reports on metrics, findings, risks and trends
Minimum Requirements:
- Bachelor's degree in a scientific discipline / Life Sciences (e.g., Biology, Microbiology, Chemistry or Pharmacy).
- 3+ years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry.
- Previous work in a Front Line QA organization, QC, Research, Development, Manufacturing or Quality role required.
#LI-Onsite
Our BenefitsCSL 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 usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL SeqirusWatch our ‘On the Front Line’ video to learn more about CSL Seqirus
