GxP Jobs

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Lead Quality / GxP Auditor

AR Val Services

•

Durham, North Carolina, USA

Contract

Lead Quality/GxP Auditor Responsibilities: Identify, analyze, and determine solutions regarding capability gapsPartner with the business to define what a qualified RTP team member looks like based on their job responsibilities then design an appropriate curriculumCreate, revise, and implement training and related documents, ensuring they are well written, executable, and compliant with applicable policies/proceduresFacilitate the review of documents and training materials to ensure compliance an
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Posted 4 hours ago

GxP Validation Expert

Altezzasys

•

Richmond, Virginia, USA

Full-time

Position: GxP Validation Expert Location: Virginia (onsite 2-3 Days in a week) Must have skills : Quality leadership (Strong), SAP Activate Methodology (Capable), Testing concepts (Strong) Job Description : GxP Validation Expert for an SAP S/4HANA implementation for a Pharma company in the US. Responsibilities: Identifies the applicable laws, standards and best practices applicable to the project such as GAMP5, 21 CFR Part 11, 21 CFR Part 211, ICH Guidelines, SAP Activate methodology.Performs
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Posted 1 day ago

GxP Validation Expert -Richmond, Virginia

Aroha Technologies

•

Virginia, USA

Contract

Position: GxP Validation Expert Location: Look for Local candidate in Richmond, Virginia (2-3 Days in a week) Must have skills : Quality leadership (Strong), SAP Activate Methodology (Capable), Testing concepts (Strong) Job Description : GxP Validation Expert for an SAP S/4HANA implementation for a Pharma company in the US. Responsibilities: Identifies the applicable laws, standards and best practices applicable to the project such as GAMP5, 21 CFR Part 11, 21 CFR Part 211, ICH Guidelines
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Posted 6 days ago | Updated moments ago

Computer Systems Validation Consultant

Kellton

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Hazelwood, Missouri, USA

Contract

Computer Systems Validation Consultant Hazelwood, MO 63042 12 months Pay Rate: $52/hr on W2 Job Summary: Interprets and understands relevant GxP regulations and standards and provides coaching/guidance to ensure enforcement and consistent application of GxP requirements Executes, manages and documents the periodic reviews of global GXP IT systems Review and provide coaching/oversight for non-GxP changes (MOCs) Authors and/or reviews GxP technical documents (SOPs, Work Instructions, Risk Assessme
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Posted 21 hours ago | Updated 4 hours ago

IT Quality Validation / System Validation / Pharmaceutical (hybrid)

Kellton

•

Nutley, New Jersey, USA

Contract

I am working on this long term contract position for one of my major Pharmaceutical clients . They are looking for string IT Quality validation and Pharmaceutical industry experience. IT Quality Validation Consultant Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports. Prepare Change Control documentation. Execute test scripts. Perform risk assessments. Must be familiar with 21 CFR Part 11. Consult
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Posted 19 days ago | Updated 14 days ago

CSV/Validation Lead

Amaze Systems Inc

•

King of Prussia, Pennsylvania, USA

Full-time, Third Party, Contract

Job title CVS Lead Location KOP, PA(Hybrid) Contract 12+ months JD- Keywords CSV, Computer System Validation, Product Serialization, DSCSA Roles and Responsibilities 10 years' Experience in Validating SAP/N systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP/Non Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP ap
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Posted 13 days ago | Updated moments ago

Senior Director, Medical Safety Science

Milestone Technologies, Inc.

•

San Mateo, California, USA

Contract

Sr Director of Medical Safety (Operations) - NO C2C Location: Foster City, CA.(requires on-site time) MUST BE LOCAL CANDIDATES Contract length:6 months to start - possibility of contract to hire. Compensation: The estimated pay range for this position is USD $120/Hr - USD $135/Hr and is an Exempt role. Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and l
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Posted 14 days ago

Project Manager

Tekniforce

•

Raleigh, North Carolina, USA

Contract

We are looking for a Project Manager. This is a six (6) months contract position in Raleigh, North Carolina with our client. In this role you would act as a primary liaison with technical and business stakeholders, manage project costs, risks, and deliverables in companys SDLC process. Responsibilities as Project Manager: Creation and maintenance of project plans, project initiation documents, weekly status reports, closing docs, and scheduling/leading regular meetings with sponsors, stakeholder
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Posted 18 days ago | Updated 11 days ago

Equipment Validation Engineer

Pyramid Consulting, Inc.

•

Summit, New Jersey, USA

Contract

Immediate need for a talented Equipment Validation Engineer. This is a 06+ Months Contract opportunity with long-term potential and is located in Summit, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:24-21967 Pay Range: $70 - $77/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Maintains qualified equi
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Posted 1 hour ago

Technical Writer-Onsite-Pittsburgh, PA

Accuro Group

•

Pennsylvania, USA

Part-time, Third Party, Contract

Hello Hope you are doing great, We have an urgent requirement of Technical Writer if you feel interested, please revert me with your updated resume. Position: Technical Writer Location: Pittsburgh, PA 100% Onsite. Duration: 12+ Months Contract Desired Competencies (Technical/Behavioral Competency) Role name: Technical Writer Role Description: Creating technical documentation (Quality Plans, System Design Specifications, SRS, URS, Data Integrity Plan, etc) to support the agile delivery of both
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Posted 21 days ago | Updated 2 hours ago

Sr. Google Cloud Platform Quality Assurance Specialist

Zachary Piper Solutions, LLC

•

Atlanta, Georgia, USA

Full-time

Piper Companies is searching for an experienced Google Cloud Platform QA Professional to join a global biopharmaceutical company producing therapies for neurology and rare disease disorders as Senior Quality Assurance (Google Cloud Platform) Specialist . The Sr. QA Specialist will be responsible for the auditing and oversight of all QA compliance GxP activities within their assigned area. The Sr. QA Specialist opportunity is preferred as HYBRID in Atlanta, GA when not traveling for audits. Resp
Posted 19 hours ago | Updated 6 hours ago

Pharma SFDC Test Lead

eTeam, Inc.

•

Remote

Contract, Third Party

Must have 15+ years of experience in SFDC and GxP validation testing on pharmaceutical domain both manual and automation testing on onsite/offshore deliverable model handling with multiple applications.Experience in test effort estimation & resources planning across all the projects. Responsible for demand/capacity planning, resource management, stakeholder managementExperience in writing/enhancing of Test Plan, Test Strategy defining of in scope , out scope , testing approach , project milesto
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Posted 25 days ago | Updated 20 days ago

Pharma Lab IT Support Engineer - Cambridge MA (Onsite)

Sailotech

•

Cambridge, Massachusetts, USA

Full-time, Third Party, Contract

Position: Pharma Lab IT Support Engineer Location: Cambridge MA (Onsite) Duration:12 months Required Skills: BS in Science, Computer/Information Technology, Bioinformatics or Engineering. Six plus years of progressively advancing experience in: Pharmaceutical operations or software development in pharmaceutical environment. Process automation of laboratory systems, information systems Proficient knowledge of computer system development life cycle concepts, change control systems and FDA regul
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Posted 32 days ago | Updated 2 hours ago

CSV Specialist

Zachary Piper Solutions, LLC

•

Spring Lake, Michigan, USA

Full-time

Piper Companies is seeking a CSV Specialist to join a rapidly growing pre-clinical research company in the Spring Lake, MI area. The CSV Specialist will be responsible for managing computer validation projects and creating test protocols. Responsibilities of the CSV Specialist includes: Review test results within computer system and implement changes Work collaboratively with internal teams, specifically QA (quality assurance) in development and implementation of computer validation programs for
Posted 3 days ago | Updated 6 hours ago

Lab System Support/ Site MFG & QC Lab Support || El Segundo, CA

E-Solutions, Inc.

•

El Segundo, California, USA

Third Party, Contract

Job Title: Lab System Support/ Site MFG & QC Lab Support Location: El Segundo, CA (Onsite 5 days a week) Project Scope: Team needs onsite Lab Support Specialists for the MVP01 (Oceanside) and RDMC (Santa Monica) QC Labs. The scope includes efficient and reliable operation of internal desktop lab systems and will handle tactical matters such as service requests as well as when working on larger projects. Scope of Services Workstation support, including direct support to end-users ranging from
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Posted 18 days ago | Updated moments ago

QA Auditor II (Remote)

Thermo Fisher Scientific

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Remote or New York, New York, USA

Full-time

Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing
Posted 14 hours ago | Updated moments ago

CSV Specialist

Zachary Piper Solutions, LLC

•

Michigan, USA

Full-time

Piper Health & Sciences is seeking an experienced Computer Systems Validation (CSV) Specialist to join a rapidly growing life sciences organization in the Greater Grand Rapids, MI area. Responsibilities for the CSV Specialist include: Collaborate with QA leadership in order to develop and implement new, efficient CSV programs for a GLP-regulated environment. Conduct internal audits/assessments to identify computerized system validation needs, or host and assist in external audits, as needed. Ass
Posted 5 days ago | Updated 6 hours ago

Quality Assurance Specialist (Clinical Trials)

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Health and Sciences is actively seeking a Quality Assurance Specialist with proven knowledge of Google Cloud Platform across all phases of Clinical Research. The Quality Assurance Specialist will support implementation and maintenance of the Quality Management System and drive compliance to all relevant GXPs. This is a Monday - Friday traditional hours opportunity, that is HYBRID. Candidates may sit in either Atlanta, GA or Raleigh, NC and will be asked to go into the office 2-days a week.
Posted 3 days ago | Updated 6 hours ago

IT System Support (lab)

OrbITpeople

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California, USA

Third Party, Contract

Lab System Support Location: El Segundo, CA - onsite 5 days a week Must Have's: The hiring team would like to emphasize that the QC Lab related activities listed on the JD are crucial as well as predominantly Lab Support experience (so hands on GxP is mandatory). Please be sure your candidates have this experience before submitting. Thank you in advance! Project Scope: Client needs onsite Lab Support Specialists for the MVP01 (Oceanside) and RDMC (Santa Monica) QC Labs. The scope includes ef
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Posted moments ago

Instrument Validation Specialist - Contractor

EY

•

West Point, Pennsylvania, USA

Contract

Contract Description We currently have a contract opportunity for an Instrument Validation Specialist - Contractor to assist our client with the validation of their laboratory equipment through a hybrid work schedule. Develop, review, and execute validation protocols for laboratory instruments, including qualification activities such as IQ (Installation Qualification), OQ(Operational Qualification), and PQ (Performance Qualification) within the manufacturing division of the client. Monitor and a
Posted 21 days ago | Updated 6 hours ago