Quality Systems Lead — CAPA & Compliance Champion
BioSpace
A global biotechnology company in Raritan, NJ, is seeking a Quality Systems Lead to oversee compliance and quality processes within a cell therapy manufacturing facility. The ideal candidate has a Bachelor's degree in a relevant field, at least 4 years of experience, and a strong understanding of quality assurance in an aseptic manufacturing environment. Responsibilities include managing CAPA programs and driving improvements in quality systems. The position offers a competitive salary and benefits package. #J-18808-Ljbffr BioSpace
$107.48k - $141.07k
Quality Systems Lead - Legend Biotech Location: Raritan, New Jersey Seniority level: Mid‑Senior level Employment type: Full‑time... ...owner for the Corrective and Preventive Actions (CAPA) process and ensures compliance within quality systems processes. Key Responsibilities...QualityFull timeTemporary workWork experience placementWork at officeWorldwideFlexible hoursShift work- Johnson & Johnson Innovative Medicine in New Jersey is seeking two Analyst, Quality Systems positions located in Raritan. The role focuses on maintaining quality system execution activities, documentation, and global process alignment. The position requires a minimum of...Quality
$65k - $104.65k
Johnson & Johnson is seeking an Analyst for Quality Systems located in Raritan, NJ. The role involves executing quality system activities and ensuring compliance with document management processes. Ideal candidates will hold a relevant bachelor's degree and possess at least...Quality$81.04k
...metrics across multiple quality functions including:... ...maintenance + tracking, compliance, + operations. May assist... ...: Investigations, CAPAs/CPIs, Planned Deviations... ...conducting investigations leading to root cause and closure... ...with Quality System; and tracking and trending...Quality- ...Collaborating to complete deliverables with global Quality Teams. Reviewing Quality System reports in Veeva QMS and associated dashboards to support... ...general support of QMS processes as needed (Deviation, CAPA, Document Control, Change Control). Requirements:...Quality
- ...-care (POC) diagnostic systems, including hematology analyzers... ...our U.S.-based quality management system and integrating... ...Systems Manager to lead FDA 510(k) and CLIA... ...of U.S. QMS. Ensure compliance with FDA QSR and ISO 13... ...Manage document control, CAPA, training, and audits....QualityOverseas
$150.8k - $226.2k
...implementation of the quality strategy closely aligned... ...with adequate quality and compliance guidance in close... ...of reports, and their CAPAs, etc.) from a PV Quality... ...PV inspections/Audits. Lead in a proactive and strategic... ...with GxP Quality Systems and Compliance provide...QualityLocal areaWorldwide$83.71k - $109.87k
Legend Biotech US, based in Raritan, NJ, is seeking a QA Lab Compliance Specialist III to provide oversight of Quality Control Laboratories. This role involves ensuring compliance with global standards and supporting regulatory inspections and audits. Candidates must hold...Quality- ...oversee investigations, ensure timely completions, and enhance compliance processes. You will work closely with team members and assist in... ...or Science and at least three years of experience as a Lead Engineer. Benefits include medical, dental, and vision insurance...Quality
$96.8k - $155k
...Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves... ...products that will continue to improve the quality of life for our consumers wherever they live... ...effectiveness. Job Title: Supply Chain Systems Integration Lead Travel Required?: Travel...QualityHourly payLocal areaWorldwideRelocation$122k - $212.75k
Johnson & Johnson Innovative Medicine seeks a Senior Manager to lead compliance monitoring efforts. The role involves managing risk assessments, ensuring quality reviews, and collaborating with cross-functional teams to uphold compliance across North America. Requirements...Quality$83.71k - $109.87k
...Biotech is seeking a QA Laboratory Compliance Specialist III as part of the Quality team based in Raritan, NJ .... ...align on root cause, corrections, and CAPAs. Provide guidance to QC in the... .../remediate gaps in processes or systems. Experience reviewing GMP documentation...QualityPermanent employmentFull timeTemporary workFor contractorsWork experience placementWork at officeLocal areaImmediate startWorldwideFlexible hours$21.15 - $36.25 per hour
...inventory and visually inspect shipments for quality. Key Duties & Responsibilities... ...Document and report damages to supervisors or leads Pack, seal, and label materials/... ...Opportunity Employer and is committed to compliance with all federal, state, and local laws...QualityLocal areaFlexible hoursShift work- ...mission centers on delivering only the best quality talent, the first time and every time. We... ...and Nursing. Job Description Title: Lead Clinical Research Associate Location: Raritan... ...• Development, execution, management and compliance assurance of the Monitoring Plan • Review...Quality
- ...Hematologic Oncology and Transplant Lead. Join the team transforming... ...understanding of the immune system - and innovative pipeline -... ...consistent with commercial compliance, legal and regulatory guidelines... ...benefits including high-quality healthcare, prevention and wellness...QualityContract workWork experience placementWork at officeLocal areaRemote workHome office
- ..., NJ, is seeking a QA Investigations Lead I to provide quality oversight during investigations in a... ...ensure timely investigations, develop CAPAs, and support regulatory audits. Applicants... ...experience in quality assurance or compliance. This position offers a competitive...Quality
$224.9k - $272.53k
...the Executive Director, Compliance Enabling QMS, this... ...roadmap for GxP Training Quality & Compliance to... ...BMS Quality Management System (QMS). The Senior Director... ...expected outcomes are met. Champion a Quality mindset /... ..., investigations, CAPAs, change management, document...QualityHourly payTemporary workFor contractorsSummer workWork at officeRemote workFlexible hours- A leading technology solutions firm is seeking a Technical Project Manager with over 8 years of experience and PMP certification... ...ensuring projects meet scope, time, budget, and quality expectations, while championing innovative solutions that impact the company's long-...Quality
$32 per hour
...Quality Specialist Guardian of Quality and Compliance by Design following the quality requirements and deliverables for... ...Promote compliance with the Management System requirements and other applicable... ...Business Experience: Leading part of a change effort. Participating...QualityHourly pay$201.91k
...design modernized platforms to replace legacy systems. Architect, design, and build comprehensive end-to-end automation capabilities. Lead the development and implementation of... ...maintenance), conducting code reviews for quality assurance, and leading or mentoring technical...QualityTemporary workWork at officeLocal areaWorldwide3 days per week$31 - $35 per hour
...Overview: Our client is a leading pharmaceutical... ...dedicated to producing high-quality products in a highly regulated... ...committed to quality, compliance, and continuous... ...Assurance and Quality Systems activities within a cGMP... ...trend (OOT) events, and CAPA activities, including root...QualityHourly payPermanent employmentTemporary workFor contractorsImmediate startMonday to Friday- Legend Biotech USA is seeking a QA Laboratory Compliance Specialist III based in Raritan, NJ. This role involves providing quality and compliance oversight for testing Advanced... ...well as ability to manage nonconformance and CAPA processes. On-site presence is expected...Quality
- ...Piscataway, NJ, is seeking a Direct Materials Procurement Lead to manage end-to-end sourcing of direct materials and... ...negotiate with suppliers to achieve cost savings while ensuring quality and regulatory compliance. The role requires cross-functional collaboration with...Quality
$68.05k - $109.87k
...Raritan, NJ is seeking a QA Investigations Lead I to oversee quality investigations for a sterile GMP... ...work independently while ensuring compliance with manufacturing standards. Responsibilities... ...managing investigations, developing CAPAs, and supporting regulatory audits....Quality- ...fast-growing medical device company in New Jersey seeks a Senior Regulatory Affairs & Quality Systems Manager. This role requires leading FDA 510(k) submissions, ensuring compliance with quality standards, and managing cross-functional teams. Candidates should have a relevant...Quality
- A leading regulatory affairs company in Raritan, New Jersey, is looking for a Customer Quality Specialist. This role focuses on supporting Post Market Regulatory Affairs activities, including complaint handling and regulatory reporting. The ideal candidate should have...Quality
$26 - $35 per hour
...Leader is responsible for leading the manufacturing... ...of the art processing systems. These systems include... ...reviewed documentation to Quality Assurance in a timely... ..., and cleaning in compliance with cGMP standards. Promptly... ...to Amneal Packaging CAPAs and Standard Operating...QualityHourly payTemporary workLocal areaFlexible hoursDay shift- Global Viral Vector MSAT Lead - Global Manufacturing & Supply team, Raritan, NJ Role Overview... ...with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain teams to... ...cause investigations, risk assessments, and CAPA execution. Drive process characterization...QualityPermanent employmentFull timeFor contractorsLocal area
$20 - $26 per hour
.... We strive to provide only the highest quality vehicles to our customers in our mission... ...looking for! Position Overview The Line Lead, Detail Role is a front-line supervisor role... .... Monitor and ensure adherence to systems, policies, procedures, and performance standards...QualityHourly payFull timeWeekend work$226.28k - $377.13k
...Job Summary The Head of Quality Assurance, Drug Product... ...(CDMO). The role leads the site’s independent... ...effective, risk‑based Quality system. It is responsible for... ...leaders to assure supply and compliance while promoting a... ...across key pillars such as CAPA, change control, and...QualityContract work
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