Quality Specialist 2
4 days ago
Job Description: The Specialist R&D Quality & Compliance (R&D Q&C) is responsible for the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP), and within Kenvue policies and Standard Operating Procedures. The Specialist is responsible for participating on documentation quality review/approval of R&D Sales Samples and R&D Product Quality Complaints (PQCs). In addition to these tasks, supporting documentation maintenance and archival, quality inspections of R&D products, and in internal assessments on R&D processes specific to GxP. The Specialist must be knowledgeable to provide guidance on applicable Regulations (FDA, ICH, EU, and others) pertaining to business partners. Responsibilities: Participate in GMP documentation review and approval of sales samples including identifying opportunities to optimize release processes for agility and speed to customer sales teams. Participate in working with various functional groups, as needed, to conduct problem identification and resolution along with assisting in compiling documentation to review and approve assessments and/or investigations for R&D Product Quality Complaints (PQC). Support in the development and implementation of GMP and Quality & Compliance processes and procedures including supporting GMP documentation review and approval. Support on internal assessments of R&D GMP processes and areas and identify opportunities to streamline. Support in inspection readiness activities. Support quality inspection of supplies for R&D studies. Requirements: Experience of the overall product development process. Problem solver (proactive in providing and executing solutions). Knowledge of procedures governing R&D GMP, Analytical/Micro and GLP activities. Working knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various. product classification types (cosmetic, OTC/OTC Monograph and Medical Devices). bility to Independently plan, organize, co-ordinate, manage, and execute assigned tasks. bility to work collaboratively in team environments. Written and oral proficiency in the English language. Strong communicator with excellent interpersonal skills and diplomacy. Good conflict handling/negotiation skills.
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Specialist 2, Quality
3 weeks ago
Summit, United States Abacus Service Corporation Full timeSpecialist R&D Quality & ComplianceThe Specialist R&D Quality & Compliance is responsible for the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient, and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good...
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Quality - QA CTO Label Specialist
3 weeks ago
Summit, United States Tech Digital Full timeCTO QA Label Specialist100% Onsite Job Title: CTO QA Label Specialist Number of Positions: 2 Shift: This position is scheduled for Wed-Sat (8 pm - 6 am) Location: US-NJ-Summit West, S12PURPOSE AND SCOPE OF POSITION: The Quality Assurance Label Control Specialist at the S-12 Cell Therapy manufacturing facility is responsible for supporting site Label Control...
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Quality Assurance Specialist
3 weeks ago
Summit, United States Tech Digital Full timeQuality Assurance Specialist50% onsite PURPOSE AND SCOPE OF POSITION (Position Summary): The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Vector External Manufacturing. Primary responsibilities include the review of cGMP controlled documents such as SOPs, specifications, completed batch records,...
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Quality Assurance Specialist
4 days ago
Summit, United States Omni Inclusive Full time50% onsitePURPOSE AND SCOPE OF POSITION (Position Summary):The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Vector External Manufacturing. Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages...
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Quality - QA CTO Label Specialist
3 weeks ago
Summit, United States Tech Digital Full timeCTO QA Label SpecialistThis position is scheduled for Sun-Wed (5:45am to 3:45pm). This is a 100% onsite position. The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records. To support...
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Quality Records Specialist
3 hours ago
Summit, United States Sunrise Systems Full timeJob Title: Quality Records Specialist Duration: 12 Month Contract (Possible extension based on work performance) Location: Summit, NJ 07901 Onsite Position Work Schedule: Mon - Fri, Business Hours ABOUT ROLE: Must Haves: - 1+ years in Cell Therapy - 1+ years in biomanufacturing - 1+ years in biotherapeutics - 1+ years in QA/QC PURPOSE AND SCOPE OF POSITION:...
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Quality - QA CTO Label Specialist
4 days ago
Summit, United States Mindlance Full timeJob Description: This is a 100% onsite position.This position is scheduled for Sun-Wed (6:30 am -4:30 pm).PURPOSE AND SCOPE OF POSITION:The Label Control Specialist at the S-12 Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at S-12 in accordance with client policies, standards, procedures and Global cGMPs....
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Cell Therapy PMO
2 weeks ago
Summit, United States TechDigital Group Full timeAn established industry player is seeking a Project Management Specialist to support a cutting-edge cell therapy facility. This role involves executing project activities, collaborating with various departments, and ensuring projects are completed within quality metrics and timelines. The ideal candidate will have a strong background in project management,...
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Quality - Quality Records Specialist
1 week ago
Summit, United States Tech Digital Full timeGlobal Supplier Quality, External Qc Quality RecordsLocation: Summit, NJPurpose And Scope Of Position: The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL). Other duties may include; coordinate shipping and testing of samples for lot release, PPQ, PSQ and w...
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Quality Assurance Label Specialist
7 hours ago
Summit, New Jersey, United States Integrated Resources, Inc ( IRI ) Full timePay Range: $32 - $34.96/hrREQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:• Must have knowledge and experience with GMP, Quality, and compliance.• Able to write and review technical reports with clarity and brevity; provides guidance to otherteam members in technical writing skills.• Requires moderate direction to complete more complex tasks;...