Current jobs related to QC Investigation Specialist - Raritan, New Jersey - Proclinical
-
QC Microbiology Specialist
3 days ago
Raritan, New Jersey, United States Legend Biotech Full timeJob Title: QC Microbiology Specialist - Lentivirus Vector ManufacturingLegend Biotech is a global biotechnology company dedicated to developing advanced cell therapies for life-threatening diseases. We are seeking a highly skilled QC Microbiology Specialist to join our Quality team in Raritan, NJ.Job Summary:The QC Microbiology Specialist will be responsible...
-
QC Microbiology Specialist
5 days ago
Raritan, New Jersey, United States Legend Biotech Full timeJob SummaryLegend Biotech is seeking a highly skilled QC Microbiology Specialist to join our Quality team in Raritan, NJ. As a key member of our team, you will be responsible for performing routine Environmental Monitoring sampling of the Lentivirus Vector (LVV) facility to support clinical trials and commercial operations in a controlled GMP environment.Key...
-
Cell Therapy Quality Assurance Specialist
7 hours ago
Raritan, New Jersey, United States Legend Biotech US Full timeJob Title: QC Data ReviewerLegend Biotech US is seeking a highly skilled QC Data Reviewer to join our Quality team based in Raritan, NJ.Job SummaryThe QC Data Reviewer is an exempt level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of cell...
-
Analytical Validation Specialist
2 weeks ago
Raritan, New Jersey, United States Piper Companies Full timePiper Companies is seeking a highly skilled Analytical Validation Specialist to support commissioning and decommissioning activities for a major pharmaceutical company in the industry.Key Responsibilities:Pharmaceutical Laboratory Operations: The successful candidate will have extensive experience in pharmaceutical laboratory operations, including laboratory...
-
Maintenance Specialist
4 days ago
Raritan, New Jersey, United States Legend Biotech US Full timeJob Title: Maintenance SpecialistLegend Biotech US is seeking a skilled Maintenance Specialist to join our Technical Operations team in Raritan, New Jersey.Job SummaryWe are looking for a highly motivated and experienced Maintenance Specialist to provide maintenance support and mechanical system operations for our cGMP Clinical and Commercial Cell Therapy...
-
Operations Specialist
5 days ago
Raritan, New Jersey, United States Legend Biotech US Full time{"Role Overview": "Operations SpecialistThis position plays a critical role in ensuring the smooth operation of our cGMP Clinical and Commercial Cell Therapy Manufacturing plant. As an Operations Specialist, you will provide operational support to the Technical Operations team, partnering with them to drive and implement improvements in manufacturing...
-
Maintenance Specialist
4 days ago
Raritan, New Jersey, United States Legend Biotech US Full timeJob Title: Maintenance SpecialistLegend Biotech US is seeking a skilled Maintenance Specialist to join our Technical Operations team in Raritan, New Jersey.Job SummaryWe are looking for a highly motivated and experienced Maintenance Specialist to provide maintenance support and mechanical system operations for our cGMP Clinical and Commercial Cell Therapy...
-
Behavioral Support Specialist
2 weeks ago
Raritan, New Jersey, United States Delta Community Supports Full timeJob SummaryWe are seeking a highly skilled and experienced Behavioral Support Specialist to join our team at Delta Community Supports. As a key member of our clinical staff, you will be responsible for providing oversight of behavioral programming for our community-based services.Key ResponsibilitiesSupervise and coach Behavior Support Specialists, as...
-
Maintenance Specialist
2 weeks ago
Raritan, New Jersey, United States Legend Biotech US Full timeAbout the RoleLegend Biotech US is seeking a highly skilled Maintenance Specialist to join our Technical Operations team based in Raritan, New Jersey. As a key member of our team, you will be responsible for providing maintenance support and mechanical system operations for our cGMP Clinical and Commercial Cell Therapy Manufacturing facilities.Key...
-
Quality Assurance Specialist
4 days ago
Raritan, New Jersey, United States Legend Biotech US Full timeJob Title: QA Shop Floor SpecialistLegend Biotech US is seeking a highly skilled QA Shop Floor Specialist to join our Quality Operations team based in Raritan, New Jersey.Job SummaryThe QA Shop Floor Specialist will be responsible for providing quality oversight of all aspects of the cell therapy clinical manufacturing process. This includes supervising...
-
Quality Assurance Specialist
3 days ago
Raritan, New Jersey, United States Legend Biotech US Full timeJob Title: QA Shop Floor SpecialistLegend Biotech US is seeking a highly skilled QA Shop Floor Specialist to join our Quality Operations team based in Raritan, New Jersey.Job SummaryThe QA Shop Floor Specialist will be responsible for providing quality oversight of all aspects of the cell therapy clinical manufacturing process. This includes supervising...
-
Senior Validation Specialist
2 days ago
Raritan, New Jersey, United States Piper Companies Full timeAbout the RolePiper Companies is seeking a highly skilled Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical company in the Raritan, NJ area.Key ResponsibilitiesExperience in Pharmaceutical Laboratory OperationsFamiliarity with laboratory instrument selection, installation (IQ/OQ) and...
-
Desktop Support Specialist
6 days ago
Raritan, New Jersey, United States LTIMindtree Full timeAbout the RoleLTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies.As a digital transformation partner to more than 700+ clients, LTIMindtree brings extensive domain and technology...
-
Analytical Validation Specialist
2 weeks ago
Raritan, New Jersey, United States Piper Companies Full timeAbout the RolePiper Companies is seeking a highly skilled Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical company.Key ResponsibilitiesPharmaceutical Laboratory Operations: The successful candidate will have experience in pharmaceutical laboratory operations, including laboratory instrument...
-
Desktop Support Specialist
5 days ago
Raritan, New Jersey, United States LTIMindtree Full timeAbout UsLTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700+ clients, LTIMindtree brings extensive domain and technology expertise...
-
Desktop Support Specialist
4 days ago
Raritan, New Jersey, United States LTIMindtree Full timeAbout UsLTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700+ clients, LTIMindtree brings extensive domain and technology expertise...
-
Desktop Support Specialist
2 days ago
Raritan, New Jersey, United States LTIMindtree Full timeAbout LTIMindtreeLTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies.As a digital transformation partner to more than 700+ clients, LTIMindtree brings extensive domain and technology...
-
Customer Service Representative
3 days ago
Raritan, New Jersey, United States Quidel Corporation Full timeAbout the RoleWe are seeking a highly skilled Customer Service Specialist 1 to join our team at QuidelOrtho. As a key member of our customer-facing team, you will be responsible for providing exceptional service to our internal and external customers, ensuring their needs are met in a timely and professional manner.Key ResponsibilitiesCreate, enter, and...
-
Support Coordinator
2 weeks ago
Raritan, New Jersey, United States Alternatives Inc. Full timeJob DescriptionAt Alternatives Inc., we are dedicated to providing exceptional support services to adults with developmental and intellectual disabilities. Our team is passionate about making a positive impact in the lives of our clients, and we are seeking a highly skilled and compassionate Support Coordinator to join our team.Key...
-
Support Coordinator
7 days ago
Raritan, New Jersey, United States Alternatives Inc. Full timeAbout the RoleAt Alternatives Inc., we are seeking a highly skilled and compassionate Support Coordinator to join our team. As a Support Coordinator, you will play a vital role in ensuring individuals with developmental disabilities and mental illnesses receive the best possible support services.Key ResponsibilitiesInvestigate and Develop Community-Based...
QC Investigation Specialist
4 months ago
QC Investigation Specialist (Level 1, 2, 3, & Senior) - Contract - Onsite
Proclinical Staffing is seeking a QC Investigation Specialist (Level 1, 2, 3, & Senior) to join a global biotech company. This is a contract role located in Raritan, NJ.
Primary Responsibilities
The QC Investigations Specialist, CAR-T Manufacturing is an exempt level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Skills & Requirements:
Minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is requiredRelevant work experience, preferably within a biological and/or pharmaceutical industry is required. Quality Control experience is required.Experience with leading investigations is required.Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is a plus.Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.Detailed knowledge of CAR-T QC test methods and related equipment is preferredExcellent written and oral communication skill are requiredCandidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.Comfortable with speaking and interacting with inspectors.Level I: 1-2 years of experienceLevel II: 2-4 years of experienceLevel III: 4-6 years of experienceSenior: 6+ years of experienceThe QC Investigation Specialist will:Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.Review/complete routine CAR-T manufacturing nonconformance/deviation investigations.Proactively work with stakeholders to implement effective CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories.Provide recommendations for the improvement of processes by working cross functionally with multiple stakeholders.Work closely with management to propose/execute improvements through the change management system.Ability to respond with a high degree of urgency to departmental and cross functional needs and requests.Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA).Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) orProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDCQA
