GxP IT Quality Assurance Specialist
Orion Innovation
Orion Innovation is seeking a seasoned GxP IT Quality Assurance professional in New Jersey to lead QA activities for GPS and R&D computerised systems. The role covers validation lifecycle, regulatory compliance, and cross-functional collaboration with IT validation and business teams. Ideal candidates will have bio/pharma industry experience, knowledge of GMP/GCP/GLP, and familiarity with REMS and Veeva systems, along with strong analytical and communication skills. #J-18808-Ljbffr Orion Innovation
- ...transformation and product development rooted in digital strategy, experience design, and engineering. The QA professional will lead GxP IT QA efforts across GPS and R&D regulatory compliance through the software validation lifecycle. Ideal candidates will have GMP/GCP/...Suggested
$96.8k - $137k
...Palmolive, we are transforming our Quality organization to be proactive,... ...a Digital Quality Systems Specialist - Governance, Analytics and Automation... ..., data integrity standards, GxP regulatory requirements in... ...sites.Collaborate with Global IT on the integration initiatives...SuggestedHourly payLocal areaRelocation- ...Contract Research Organization services. It is one of the market leaders in certain... ...: Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are... ...requirements. Trains laboratory personnel in GXP/ISO procedures, practices, and...SuggestedFull timeContract workFor subcontractorMonday to Friday
- ...MRP Solutions, a plastic cap manufacturer, is seeking a Quality Support Specialist to own investigations of product and process deviations and ensure compliance with Food Safety guidelines, GMPs and SOPs. The role interacts with Operations, Continuous Improvement and...Suggested
- ...Advancement Job Summary We are seeking an experienced Quality Assurance Specialist to join our team. In this role, you will be responsible... ...labeling, distribution, and returns. This role supports GxP operations, oversees Quality System activities, and collaborates...SuggestedWorldwide
$70k - $75k
...our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. The Quality Assurance Specialist is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway, NJ. This employee will be...Full timeWork at officeLocal areaFlexible hours$85k - $100k
Description The Quality Assurance Specialist is responsible for ensuring products and processes meet quality standards through validation activities, quality investigations, complaint handling, process monitoring, and continuous improvement initiatives. This role partners...Flexible hours- ...Quality Assurance Specialist Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic... ...Kaushik Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - (650)-399...Work at office
$57.5k - $83.4k
...that values continuous improvement, teamwork, and excellence in every aspect of our business. Primary Purpose The Quality Assurance Specialist is responsible for ensuring consistent service quality by conducting comprehensive onsite quality assurance audits...Full timeTemporary workPart timeSecond jobWork at officeLocal areaFlexible hours$79k - $127.65k
...Function: QualityJob Sub Function: Quality & Compliance AuditJob... ...Pharmacovigilance QA Auditor Specialist to be located at Raritan, NJ;... ...a Pharmacovigilance Quality Assurance Auditor Specialist you will be... ...facilities and processes in GxP/non-regulated areasSupports regulatory...Full timeWork experience placementWork at officeLocal areaImmediate start- ...Job Description Job Description Role: Sr. Quality Assurance Engineer. 100% onsite. Not a QC role. We need QA candidates who have owned... ...intelligence, productivity, business, and enterprise solutions. It supports organizations worldwide through platforms and...Worldwide
$81.27k - $106.67k
...Position QA Change Control Specialist II - Quality team, Raritan, NJ Role Overview... ...facility, in quality assurance, manufacturing compliance, clinical... ...quality, or cell therapy. GxP Quality лёSystem knowledge... ...conflict‑resolution skills. IT system lifecycle knowledge,...Permanent employmentContract workTemporary workWork experience placementWork at officeLocal areaWorldwideFlexible hoursShift work- ...Description: Working in a cross-functional virtual plant team, this quality manager provides quality oversight of Contract Manufacturing... ...is to support management of CMO disposition documentation, assure CMO compliance and applicable current Good Manufacturing Practices...Contract workWork at officeFlexible hours
- Quality Assurance Specialist, Designated Complaint Unit (Americas) - Hybrid 5 days ago Be among the first 25 applicants WSA is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential...Work at officeLocal areaEarly shift
- ...experience. • Animal health GLP auditing experience. Job Title: Quality Specialist- II -Hybrid Job Location: Rahway NJ Duration: 2 years... ...Global Research & Development organization. Serve as the Quality Assurance Unit (QAU) in compliance with VICH GL9 (GCP), FDA 21 CFR...
- Kashiv BioSciences, LLC is seeking an MQA Specialist I, II, or III to ensure cGMP compliance across manufacturing, labs, and quality systems. You will review materials, release batches, and support audits with cross-functional teams in a biologics environment. The role...
- FOCO is a world-leading manufacturer of sports and entertainment merchandise. This Quality Assurance & Compliance Associate role supports U.S.-based quality operations, ensuring products meet safety and compliance standards before shipment. Join FOCO’s Supply Chain Quality...
$36 - $46 per hour
...structured environments, and enjoys ensuring that systems and processes perform exactly as intended. About the Role As a Quality Assurance Specialist, youll serve as the checkpoint for accuracy and consistency across our workflows. Youll verify execution against SOPs,...Hourly payContract workLocal areaRelocation$63k - $93k
Innophos is hiring a Quality Assurance Documentation Specialist- Supplier Quality in our Cranbury, NJ location. The Quality Assurance Documentation Specialist will assist in developing, facilitating and continually improving the Supplier Quality (SQ) Documentation Processes...Work at officeLocal areaRemote work- ...ecommerce, and education. Must Have's quality assurance mindset for computer system validation... ...expertise to read and interpret global GXP regulations, as well data integrity expectations... ...activities associated with the GxP IT Quality Assurance (QA) program for GPS and...
$70.67k - $92.76k
QA Document Control Specialist I/II/III Legend Biotech is a global biotechnology... ...with safety policies, quality systems and cGMP requirements... ...facility, quality assurance, manufacturing compliance, clinical... ...cell therapy. Knowledge of GxP quality systems and relevant...Work experience placementFlexible hours- ...Legend Biotech in Raritan, NJ seeks a QA Shop Floor Specialist to oversee quality during autologous CAR-T production in a cGMP cleanroom. You will ensure compliance with GDP, review SOPs, and support batch release in SAP for in-house reagents. The role requires 0-2+ years...Weekend work
- ...Product recall/field alert management. Assist with review of Quality Agreements For applicable products, coordinate with Contract... ...or Microbiology is preferred ~1 to 2 years of Quality Assurance or related pharmaceutical industry experience is preferred. Recent...Contract workWork at office
$69.5k - $102.35k
Johnson & Johnson, QA Specialist II (1 of 2) - Application via WayUp Join to apply for the Johnson & Johnson, QA Specialist... ...health for humanity. Learn more at Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations:...Contract workTemporary workPart timeLocal areaImmediate startAfternoon shift- A biotechnology company in New Jersey seeks a QA Change Control Specialist II responsible for quality oversight in a cell therapy manufacturing facility. Applicants should possess a Bachelor's degree in Science and a minimum of two years' experience within a cGMP environment...
$96.27k - $126.35k
...multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey . Role... ...an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations...Permanent employmentFull timeTemporary workFor contractorsWork experience placementLocal areaImmediate startWorldwideFlexible hoursWeekend workAfternoon shift- Legend Biotech US is seeking a QA Shop Floor Specialist to provide quality oversight of autologous CAR-T production on the manufacturing floor within a controlled cGMP cleanroom environment. The role ensures compliance with GDP, SOPs, and regulatory standards while supporting...
- Legend Biotech is seeking a QA Shop Floor Specialist in Raritan, New Jersey. The role sits in Quality Operations and ensures floor quality oversight for autologous CAR-T product production in a controlled cGMP environment. Schedule: Wed-Sat, 2nd Shift, on-site at the manufacturing...Afternoon shift
- Legend Biotech US is seeking a QA Shop Floor Specialist in Raritan, New Jersey, to provide quality oversight in the production of CAR-T products. This exempt-level position involves maintaining compliance in a cGMP cleanroom and supporting manufacturing activities. You...
$70k - $90k
A leading hearing aid company seeks a Quality Assurance Specialist for their Designated Complaint Unit. This hybrid role involves managing and resolving customer complaints, requiring proficiency in complaint handling processes and Microsoft Office tools. Ideal candidates...Work at office
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