Quality Assurance Specialist IV
1 week ago
6 Month Contract (May extend or convert to permanent)
$66/hour W2
JOB SUMMARY:
The Specialist IV provides compliance support or oversight for operational functions. This includes technical writing and authoring of quality system records such as laboratory investigations, deviations, CAPA, and change controls pertaining to operational functions supported by Quality Systems & Compliance (e.g., Quality Control).
- Conducts investigations for Laboratory Investigation Reports (LIR) and deviations via effective root cause analysis.
- Monitors completion of the quality system records and provides escalation to management, as needed.
- Generates and analyzes metrics for operational activities, including but not limited to laboratory investigations and invalid assays and other laboratory operation parameters as appropriate.
- Authors and/or revises other controlled documents such as procedures, methods, work instructions, protocols, and reports as applicable.
- Ensures personnel compliance of corresponding training programs for supported operational functions.
- Provide technical writing in support of operational functions, such as Quality Control (QC).
- Responsible for authoring Out of Specification (OOS) and anomalous event laboratory investigations, deviations, CAPA, and change controls.
- Perform risk analysis as needed to determine severity, likelihood of recurrence when triaging events and/or conducting investigations.
- Conduct investigations thoroughly for OOS events according to the phase-based approach per FDA and Annex guidelines.
- Investigate deviations to identify root cause and contributing factors and in parallel assess impact to patients, product quality, data integrity, validated state, and regulatory compliance.
- Identify and develop relevant and effective CAPA.
- Address impact to systems, processes, product, and any regulatory requirements when authoring change controls.
- Prioritize and monitor completion of lab investigations, deviations, CAPA, and change controls.
- Maintain expected standards with concise technical writing using correct grammar, detailed and accurate information, to be completed within established timelines.
- Generate and analyze metrics as applicable.
- Manage and author change controls related to qualification, modification, and/or decommissioning of equipment.
- Possess a strong understanding of data integrity principles.
- Ensure compliance of personnel with corresponding training program(s).
WORK ENVIRONMENT and PHSYICAL DEMANDS:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 10 pounds at times.
EXPERIENCE:
- A minimum of 3 years work experience within a GMP environment working with small and/or large molecules.
- Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC (Waters Empower software is preferred), and Relative Potency Assay.
- Solid technical training and troubleshooting experience are essential.
- Strong understanding of data integrity principles within a GMP environment is required.
PREFERRED ADDITIONAL SKILLS (I.E., COMPUTER):
- Expertise in use of Microsoft Office applications.
Education:
- Bachelor's in biology, biochemistry or related pharmaceutical-biotechnology discipline is required.
-
Quality Assurance Specialist IV
1 week ago
Newark, California, United States Meet Full timeJob Title: Quality Assurance Specialist IVMeet our team of experts in quality assurance and join us in upholding the highest standards of regulatory compliance and product integrity.Job Summary:We are seeking a highly skilled Quality Assurance Specialist IV to join our team. As a key member of our quality assurance department, you will be responsible for...
-
Quality Assurance Specialist
1 week ago
Newark, United States Rangam Full timeJob Title: Quality Assurance Specialist IVJob Summary:The Specialist IV provides compliance support or oversight for operational functions.This includes technical writing and authoring of quality system records such as laboratory investigations, deviations, CAPA, and change controls pertaining to operational functions supported by Quality Systems &...
-
Quality Assurance Specialist IV
1 week ago
Newark, United States Meet Full timePosition Overview:This role involves technical writing, conducting thorough investigations, and monitoring quality system records to uphold regulatory compliance and product integrity.Key Responsibilities:Provide compliance support for operational functions, particularly in Quality Control (QC), ensuring adherence to GMP standards. Author and revise quality...
-
Quality Assurance Specialist
4 weeks ago
Newark, Delaware, United States Chili's Grill & Bar Full timeQuality Assurance SpecialistAt Chili's Grill & Bar, we're committed to delivering exceptional dining experiences to our guests. As a Quality Assurance Specialist, you'll play a vital role in ensuring that every dish that leaves our kitchen meets our high standards of quality and taste.Key Responsibilities:• Ensure that food is prepared to our company's...
-
Quality Assurance Specialist
4 weeks ago
Newark, New Jersey, United States VWR International , Inc. Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at VWR International, Inc. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.Key ResponsibilitiesConduct regular audits and assessments to ensure compliance with regulatory requirements...
-
Quality Assurance Specialist
4 weeks ago
Newark, Delaware, United States Chili's Grill & Bar Full timeQuality Assurance SpecialistAt Chili's Grill & Bar, we're committed to delivering exceptional Guest experiences. As a Quality Assurance Specialist, you'll play a vital role in ensuring our food meets the highest standards of quality and taste.Key Responsibilities:Monitor food preparation to ensure consistency and qualityCollaborate with kitchen staff to...
-
Quality Assurance Specialist
4 weeks ago
Newark, California, United States Unigen Full timeJob Title: Quality Assurance SpecialistJob Function - ManufacturingJob Overview:The Final Quality Assurance Specialist performs final and other types of quality inspection to ensure adherence of the finished product to compliance requirements and procedures. Reports to Production Supervisor and is located at Unigen HQ.Primary Job Responsibilities:1. Perform...
-
Quality Assurance Specialist
4 weeks ago
Newark, California, United States Mitac Information Systems Corp. Full timeJob DescriptionJob Title: Quality Assurance SpecialistCompany: Mitac Information Systems Corp.Location: Newark, CAPosition Type: Full TimeExperience: 1 YearEducation: Bachelor's degree in Computer Science, Electrical Engineering, Industrial Engineering, Mechanical Engineering, or related fieldDiscuss customer requirements for Corrective and Preventive Action...
-
Call Center Quality Assurance Specialist
1 month ago
newark, United States Adecco Full timeAdecco is searching for a Call Center Quality Assurance Specialist for a meal subscription company in Newark, NJ through end of the year (possible extension)! Must be able to commute to Newark, NJ 2-3 days a week.The Outbound Quality Assurance Specialist is an important part of our growing team. The main function of this role is to monitor interactions from...
-
Call Center Quality Assurance Specialist
1 month ago
Newark, United States Adecco Full timeAdecco is searching for a Call Center Quality Assurance Specialist for a meal subscription company in Newark, NJ through end of the year (possible extension)! Must be able to commute to Newark, NJ 2-3 days a week.The Outbound Quality Assurance Specialist is an important part of our growing team. The main function of this role is to monitor interactions from...
-
Call Center Quality Assurance Specialist
1 month ago
Newark, United States Adecco Full timeAdecco is searching for a Call Center Quality Assurance Specialist for a meal subscription company in Newark, NJ through end of the year (possible extension)! Must be able to commute to Newark, NJ 2-3 days a week.The Outbound Quality Assurance Specialist is an important part of our growing team. The main function of this role is to monitor interactions from...
-
Call Center Quality Assurance Specialist
1 month ago
newark, United States Adecco Full timeAdecco is searching for a Call Center Quality Assurance Specialist for a meal subscription company in Newark, NJ through end of the year (possible extension)! Must be able to commute to Newark, NJ 2-3 days a week.The Outbound Quality Assurance Specialist is an important part of our growing team. The main function of this role is to monitor interactions from...
-
Senior Registered Nurse
4 weeks ago
Newark, Delaware, United States ChristianaCare Full timeJob Title: Senior Registered Nurse - Quality Assurance SpecialistChristianaCare is seeking a highly skilled Registered Nurse to join our team as a Quality Assurance Specialist. As a key member of our clinical team, you will be responsible for ensuring the highest standards of quality and safety in patient care.Key Responsibilities:Lead and facilitate Quality...
-
Quality Assurance Specialist
1 week ago
Newark, Delaware, United States destinationone Consulting Full timeQuality Assurance Coordinatordestinationone Consulting is a leading recruitment agency specializing in diverse sectors, including Healthcare, Health Tech, Government, Municipalities, NonProfits, Legal, and Public Accounting. We are building a comprehensive database of opportunities in these fields. By applying, you ensure our recruiters can efficiently match...
-
Senior Registered Nurse
3 weeks ago
Newark, Delaware, United States ChristianaCare Full timeJob Title: Senior Registered Nurse - Quality Assurance SpecialistChristianaCare is seeking a highly skilled Senior Registered Nurse to join our team as a Quality Assurance Specialist. This role will be responsible for leading and facilitating quality assurance and performance improvement initiatives in our Thoracic Surgery department.Key...
-
Quality Assurance Specialist
4 weeks ago
Newark, New Jersey, United States VWR International , Inc. Full timeQuality Assurance AnalystThe Opportunity:At Avantor, we are committed to attracting, engaging, and hiring the right talent to drive our global performance. Our Quality Assurance & Quality Systems vertical plays a crucial role in this effort, enabling our internal teams worldwide to grow beyond their limits.The Quality Assurance Analyst is responsible for...
-
Quality Assurance Automation Specialist
4 weeks ago
Newark, Delaware, United States CAI Full timeJob SummaryWe are seeking a Quality Assurance Automation Specialist to join our development team. The successful candidate will work closely with the QA team to ensure the quality of our products.Key ResponsibilitiesAlign with project-specific QA processes to ensure control quality and provide consistency in the products that are createdHands-on experience...
-
Quality Assurance Specialist
1 week ago
Newark, Delaware, United States ViaSat Full timeQuality Inspector Job DescriptionViasat is seeking a detail-oriented Quality Inspector to join our quality assurance team. As a Quality Inspector, you will be responsible for performing thorough inspections of products before they are shipped to our customers.Key Responsibilities:Perform source inspections on In-process and Final PWAs, cable assemblies, and...
-
Quality Assurance Specialist
1 day ago
Newark, Delaware, United States Hologic Full timeQuality Engineer Job DescriptionWe are seeking a highly skilled Quality Engineer to join our team at Hologic. As a Quality Engineer, you will play a critical role in ensuring the highest standards of quality and excellence in our products.Key Responsibilities:Support evaluations, investigations, and root cause analyses to identify and address quality...
-
Quality Assurance Specialist
23 hours ago
Newark, Delaware, United States Unigen Full timeJob Title:QA Inspector - FQAJob Overview:The Final Quality Assurance (FQA) Inspector plays a critical role in ensuring the quality of finished products by performing final and other types of quality inspections. This position is responsible for ensuring adherence to compliance requirements and procedures, and reports to the Production Supervisor at Unigen HQ...