Current jobs related to Compliance Investigator, Clinical Manufacturing Specialist - Saddle Brook, New Jersey - Lynkx Staffing LLC
-
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewAs a Compliance Investigator, Clinical Manufacturing with Lynkx Staffing LLC, you will lead life-cycle investigations to improve processes by implementing corrective and preventative actions to ensure compliance. Your expertise will be crucial in determining the causes and preventative actions of deviations, non-conformances, and other issues....
-
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewLynkx Staffing LLC is seeking a highly skilled Compliance Investigator, Clinical Manufacturing to join our team. As a key member of our Life Sciences division, you will be responsible for leading life-cycle investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other quality-related issues.Key...
-
Quality Assurance Compliance Investigator
6 days ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob Title: Quality Assurance Compliance InvestigatorLynkx Staffing LLC is seeking a Quality Assurance Compliance Investigator to join our team in Allendale, NJ. As a Quality Assurance Compliance Investigator, you will be responsible for performing Quality Assurance Compliance activities in support of company and/or client procedures, including document...
-
Quality Assurance Compliance Investigator
3 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob Title: Quality Assurance Compliance InvestigatorLynkx Staffing LLC is seeking a highly skilled Quality Assurance Compliance Investigator to join our team in Allendale, NJ. As a Quality Assurance Compliance Investigator, you will play a critical role in ensuring the quality and compliance of our products and services.Key Responsibilities:Conduct...
-
Quality Control Compliance Investigator
1 month ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewLynkx Staffing LLC is seeking a highly skilled Quality Control Compliance Investigator to join our team. As a key member of our quality assurance team, you will be responsible for leading life-cycle investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other quality-related issues.Key...
-
Quality Assurance Investigator
6 days ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob Title: Quality Control Compliance InvestigatorLynkx Staffing LLC is seeking a highly skilled Quality Control Compliance Investigator to join our team in Allendale, NJ.Job Summary:The Quality Control Compliance Investigator will be responsible for leading life-cycle investigations, including deviations, environmental excursions, non-conformances,...
-
IT Security Compliance Specialist
7 days ago
Saddle Brook, New Jersey, United States Aequor Technologies Full timeWe are seeking a skilled IT Security Compliance Specialist to provide world-class IT services to our clients in the NYC metro area.This is a great opportunity for a self-starter with a proven track record to develop, implement, and support various initiatives in the area of governance, risk and compliance.Key Responsibilities:Lead the planning, scoping,...
-
Manufacturing Associate II
2 months ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled and detail-oriented Manufacturing Associate II to join our team in the biotechnology industry. As a key member of our production team, you will be responsible for processing, culturing, and manipulating cell products using aseptic techniques, adhering to written Standard Operating Procedures and...
-
Quality Assurance Investigator
7 days ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob DescriptionLynkx Staffing LLC is seeking a Quality Assurance Investigator to lead life-cycle investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other issues to improve processes and ensure compliance.Conduct investigations to determine causes and implement corrective and preventative actions.Drive...
-
IT Security Compliance Specialist
3 weeks ago
Saddle Brook, New Jersey, United States Aequor Technologies Full timeJob Title: IT Security Compliance AnalystWe are seeking a highly skilled IT Security Compliance Analyst to join our team at Aequor Technologies. As a key member of our dynamic team, you will play a crucial role in providing world-class IT services to our clients in the NYC metro area.Responsibilities:Lead the planning, scoping, execution, and documentation...
-
Manufacturing Operations Director
2 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewLynkx Staffing LLC is seeking a seasoned professional to fill the role of Associate Director, Manufacturing Operations. This position is responsible for ensuring the efficient utilization of Operations resources to meet customer demand.Key ResponsibilitiesDevelop and implement strategies to optimize Operations scheduling and training...
-
Associate Director Manufacturing Operations
4 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob DescriptionLynkx Staffing LLC is seeking a highly skilled and experienced Associate Director, Manufacturing Operations to join our team. As a key member of our operations team, you will be responsible for ensuring the efficient utilization of operations resources to meet customer demand.Key Responsibilities:Develop and implement strategies to optimize...
-
CCTO Investigator Specialist
7 days ago
Stony Brook, New York, United States Stony Brook Medicine Full timeJob SummaryThe Cancer Clinical Trials Office (CCTO) Investigator-Initiated Trial (IIT) Specialist is a critical role that requires a detail-oriented and organized professional to collaborate closely with investigators and the IIT Manager. This position provides operational support and regulatory management for investigator-initiated clinical research at...
-
Manufacturing Operations Manager
1 month ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled Manufacturing Operations Manager to join our team in Allendale, NJ. As a key member of our Life Sciences team, you will be responsible for ensuring efficient capacity utilization of site resources to meet customer demand.Key ResponsibilitiesDevelop and implement strategies to meet customer demands and...
-
Risk Management Specialist
2 weeks ago
Saddle Brook, New Jersey, United States Resorts World New York Full timeJob Title: Risk SpecialistResorts World New York is seeking a highly skilled Risk Specialist to join our team. As a Risk Specialist, you will play a critical role in analyzing payment trends and betting patterns to combat money laundering and fraud.Key Responsibilities:Review and verify patron identities and documentation to ensure compliance with regulatory...
-
Data Entry Specialist
3 weeks ago
Saddle Brook, New Jersey, United States VDart Full timeAccounting Specialist RoleVDart is seeking an experienced Accounting Specialist to join our team. As an Accounting Specialist, you will be responsible for processing company financial data and transactions from multiple business areas within Allstate.Key Responsibilities:Balances moderately complex general ledger accounts, analyzing and investigating...
-
Risk Management Specialist
6 days ago
Saddle Brook, New Jersey, United States Resorts World New York Full timeJob Title: Risk SpecialistResorts World New York is seeking a highly skilled Risk Specialist to join our team. As a Risk Specialist, you will play a critical role in analyzing payment trends and betting trends to combat money laundering and fraud.Key Responsibilities:Review and verify patron identities and documentation.Liaise with players on account and...
-
Risk Management Specialist
2 weeks ago
Saddle Brook, New Jersey, United States Resorts World New York Full timeJob Title: Risk Management SpecialistResorts World New York is seeking a highly skilled Risk Management Specialist to join our team. As a Risk Management Specialist, you will play a critical role in analyzing payment trends and betting trends to combat money laundering and fraud.Key Responsibilities:Review and verify patron identities and...
-
Accounting Specialist
6 days ago
Saddle Brook, New Jersey, United States VDart Full timeAccounting SpecialistJob Summary:As an Accounting Specialist at VDart, you will process company financial data and transactions from multiple business areas to ensure compliant and accurate processing. You will provide accounting support and expertise to internal and external customers and business partners for manual and automated financial transactions and...
-
Environmental Monitoring Specialist
4 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled Quality Control Microbiologist to join our team. As a Quality Control Microbiologist, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesPerform environmental monitoring activities, including non-viable particulate testing, active air viable, passive...
Compliance Investigator, Clinical Manufacturing Specialist
2 months ago
Lynkx Staffing LLC is seeking a highly skilled Compliance Investigator, Clinical Manufacturing to lead life-cycle investigations and implement corrective and preventative actions to ensure compliance in the Life Sciences industry.
Key Responsibilities- Determine the root causes and implement preventative actions for deviations, non-conformances, out-of-specification (OOS) and out-of-trend (OOT) investigations, as well as field complaints and environmental excursion investigations.
- Drive investigations to true root cause using appropriate investigation tools and benchmark industry standards to develop and implement investigative and impact assessment tool sets.
- Define and implement effective preventative actions to prevent recurrence and manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
- Collaborate with cross-functional teams to develop and track Corrective Action Preventive Action (CAPA) plans and identify and create appropriate trending rules that trigger corrective actions.
- Analyze process data and evaluate trends to identify major improvement opportunities and effectively utilize change management approach.
- Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process.
- Champion CAPA plans and implementation and provide communication plans for ongoing deviations and CAPAs.
- Effectively create and communicate CAPA plans to responsible parties and oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
- Bachelor's degree in a Quality/Process-related field.
- Experience in Good Manufacturing Practice (GMP) Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.
- Root cause analysis experience in pharmaceutical or FDA-regulated operations preferred.
- Experience using electronic Quality Management Systems preferred.
- Relevant IT skills (able to work with Visio, Microsoft Project, and Excel).
- Ability to think strategically and tactically (detail-oriented).
- Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment.
- Analytical and problem-solving skills.
- Strong written and oral communication skills.
- Flexible and able to adapt to company growth and evolving responsibilities.
- Integrity, accountability, and strong dedication to regulatory compliance.
- Continuous improvement mindset.
- Ability to work effectively as a team and independently.
- Quality Systems Training (Deviation/CAPA).
The employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen.
