Quality Assurance Compliance Specialist
4 months ago
- Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes.
- Develops and communicates investigation strategy to key stakeholders.
- In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log
- Reviews and approves investigations and CAPAs;
- Conducts weekly status update meetings with cross functional departments and other stakeholders.
- Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis.
- Prepares and issues change control as necessary.
- Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures.
- Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
- Conducts trend analysis of compliance related metrics such as deviations and CAPAs.
- Performs supplemental investigations and/or participates in project teams or assignment as necessary.
- Support in agency, internal and/or client audits.
- Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
- Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
- Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles.
- Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
- BS biological sciences or other relevant field of study.
- 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
- Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
- Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
- Familiar with FDA, ISO, and other regulatory agency guidelines.
- Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.
- Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
- Experience in both clinical and commercial manufacturing is preferred.
- Experience in supporting health authority inspections and/or client audits preferred.
- Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training
- Understanding and comprehension of quality system applications.
-
Quality Assurance Compliance Specialist
3 days ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance...
-
Quality Assurance Compliance Investigator
2 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled Quality Assurance Compliance Investigator to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with regulatory requirements and company procedures.Key ResponsibilitiesInvestigation and CAPA Management: Conduct thorough investigations...
-
Quality Assurance Compliance Investigator
4 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality...
-
Quality Assurance Compliance Investigator
3 days ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality...
-
Quality Assurance Manager
4 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations...
-
Quality Assurance Manager
21 hours ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations...
-
Quality Assurance Specialist
4 weeks ago
Oak Brook, Illinois, United States Integrated Talent Strategies Full timeIntegrated Talent Strategies (ITS) is in search of a Quality Assurance Specialist to join a prominent engineering and consulting firm. This role presents an array of excellent benefits, including a competitive salary, comprehensive health coverage, a 401(k) plan, and generous paid time off.QualificationsBachelor's degree in Engineering, Quality, or a related...
-
Quality Assurance Investigator
2 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled Quality Assurance Investigator to lead life-cycle investigations and implement corrective and preventative actions to ensure compliance.Key ResponsibilitiesDetermine the causes and preventative actions of deviations, non-conformances, out-of-specification (OOS) and out-of-trend (OOT) results, field...
-
Quality Assurance Manager
3 days ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight...
-
Quality Assurance Manager
4 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight...
-
Quality Assurance Specialist
2 weeks ago
Oak Brook, Illinois, United States Integrated Talent Strategies Full timeJob DescriptionIntegrated Talent Strategies is seeking a Quality Assurance Specialist to work in the Chicago area for a leading engineering and consulting firm. This position offers a competitive salary, health insurance, 401(k), and paid time off.ResponsibilitiesSupport Quality Assurance, including ISO requirements & compliance, and supplier quality...
-
Quality Assurance Associate III
2 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob DescriptionLynkx Staffing LLC is a leading staffing agency specializing in placing talented professionals in the Biotechnology, Pharmaceutical, and Medical Device industries. We are seeking a highly skilled Quality Assurance Associate III to join our team.Key ResponsibilitiesPerform Quality Assurance activities with minimal supervision, ensuring...
-
Quality Control Compliance Investigator
2 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled Quality Control Compliance Investigator to join our team. As a key member of our organization, you will be responsible for leading life-cycle investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other events to improve processes and ensure compliance.Key...
-
Quality Assurance Associate III
4 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...
-
Quality Assurance Associate III
3 days ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...
-
Quality Assurance Specialist
2 weeks ago
Stony Brook, New York, United States Actalent Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will be responsible for conducting quality control testing of incoming and outgoing materials, running capillary electrophoresis, and assisting in validation procedures and related tasks.Key ResponsibilitiesConduct...
-
Quality Assurance Specialist
5 days ago
Oak Brook, Illinois, United States Integrated Talent Strategies Full timeQuality Engineer Job DescriptionIntegrated Talent Strategies is seeking a Quality Engineer to work in the Chicago, IL area for a leading engineering and consulting firm. This position offers a competitive salary, health insurance, 401(k), and paid time off.Key Responsibilities:Support Quality Assurance, including ISO requirements & compliance, and supplier...
-
Quality Assurance Specialist
2 weeks ago
Oak Brook, Illinois, United States Integrated Talent Strategies Full timeQuality Engineer Job DescriptionIntegrated Talent Strategies is seeking a Quality Engineer to work in the Chicago, IL area for a leading engineering and consulting firm. This position offers a competitive salary, health insurance, 401(k), and paid time off.QualificationsBachelor's degree in Engineering, Quality, or a related field is required.Knowledge of...
-
Materials Quality Assurance Specialist
4 weeks ago
Pine Brook, United States Roeslein Full timeAbout Roeslein:Roeslein is a distinguished leader in the engineering and manufacturing sector, specializing in innovative solutions for the aerospace and defense industries. With a commitment to excellence and a legacy of over a century, we are dedicated to delivering high-quality products and services to our global clientele.Position Overview:The Materials...
-
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the...