QA Operations Specialist, cGMP & Validation
FUJIFILM Biotechnologies
FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Specialist, Operations to provide QA oversight of Drug Substance Manufacturing processes and validate DSM systems throughout their lifecycle. You will participate in batch and solution record reviews, real-time event triage, and KPI-driven objectives, while supporting cGMP manufacturing and continuous improvement across sites. This role requires 2+ years GMP experience or a master’s with related experience, and familiarity with validation #J-18808-Ljbffr FUJIFILM Biotechnologies
- ...Skills Research Institute is seeking a QA Specialist, Operations in Holly Springs, NC. This role... ...Manufacturing processes, ensuring compliance with cGMP regulations and facilitating... ...in a GMP environment, and knowledge of validation software. This position requires working...SuggestedShift work
- ...Biotechnologies in Holly Springs, NC, seeks a QA Specialist, Operations to oversee DSM manufacturing processes and validation programs. You will ensure operations stay in a... ...GMP quality assurance experience, knowledge of cGMP environments, and attention to policy...SuggestedShift work
- ...leading pharmaceutical company in Holly Springs, North Carolina, seeks a QA specialist to provide quality support and oversight for commissioning, qualification, and Computer Systems Validation. The role involves managing QA oversight of various automation platforms,...Suggested
- FUJIFILM Holdings America Corporation is seeking a QA Specialist for Drug Product in North Carolina. The role drives Quality... ...manufacturing readiness through startup to commercial operation, coordinating validation, lifecycle documentation, and regulatory readiness. You...Suggested
- ...Position Overview The QA Specialist, Validation is responsible for helping to drive the Quality oversight for commissioning and qualification... ..., and processes for QA support of manufacturing operations in cGMP regulated facility. Ensures project and operational quality...SuggestedFull timeFlexible hours
- FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, Validation to drive quality oversight for commissioning and qualification activities. You will review and approve validation documents, maintain validated states, and support change control in a...
- ...Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, Validation, to drive quality oversight for... ...state for equipment and processes in a cGMP facility. The role supports regulatory inspections, 24/7 manufacturing operations, and implementation of risk-based...
- ...Position Overview The QA Specialist, DSM Operations (Days 2-2-3 0600-1800) is responsible for partnering... .... This role provides oversight of validation program execution for these processes... ...support of manufacturing operations in cGMP regulated facility. Participate in...Full timeImmediate startFlexible hoursShift work
- Position Overview The QA Specialist, Operations is responsible for partnering in the Quality oversight... ...processes. This role provides oversight of validation program execution for these processes... ...of manufacturing operations in a cGMP‑regulated facility. Participates in streamlining...Immediate startShift work
- ...the intersection of biomanufacturing and digital operations. If you're excited to learn and grow while supporting cGMP production with modern tools like MES, data... ...engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event...Full timeInternship
- Lumos is looking for Service Operations Specialist to bring the future of connectivity to our customers. In this role, you'll be responsible for... ...required. High School Diploma or equivalent required. Valid, fully unencumbered Driver’s License required. Must reside...Live inLocal areaRemote workFlexible hours
- ...startup, commissioning, troubleshooting, and training of their operations staff to be able to effectively operate the new and upgraded facilities... ...search, in compliance with any applicable laws and regulations.Valid Drivers License is RequiredCertificationsWork Environment/...Full timePart timeWork experience placementWork at officeRemote workWorldwideRelocationVisa sponsorshipFlexible hours
- A leading quality assurance firm located in North Carolina is seeking a Sr. Associate in Plant Quality Assurance (PQA) to provide crucial oversight during drug substance manufacturing. This role entails ensuring compliance with GMP and quality standards while collaborating...
- ...Quality Assurance Associate to support inspections, sampling, and testing of raw materials. The role involves ensuring compliance with cGMP requirements, documenting test results, and participating in training efforts. Ideal candidates will have expertise in inspection...
- ...Staff Water Operations SpecialistTogether, we own our company, our future, and our shared success. As an employee-owned company, our people... ..., in compliance with any applicable laws and regulations. Valid Drivers License is RequiredCertifications Work Environment/Physical...Full timePart timeWork experience placementWork at officeRemote workWorldwideRelocationVisa sponsorshipFlexible hours
$24 - $26 per hour
...materials received for use in our cGMP manufacturing plants meet all... ..., and testing areas • Provide QA oversight to Warehouse and... ...2 days ago Quality Assurance Specialist - cGMP Manufacturing Holly Springs... ...I, Quality Assurance (Quality Operations) Triangle, NC $79,000.00-$103,...Contract workRemote work- This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation...
- ...support and GMP oversight for manufacturing operations Review and approve batch records,... ...investigations, and CAPAs Ensure adherence to cGMP, GDP, and internal quality procedures... ...Experience with batch records, deviations, and QA oversight Previous experience in GMP-...Shift work
- ...startup, commissioning, troubleshooting, and training of their operations staff to be able to effectively operate the new and upgraded facilities... ..., in compliance with any applicable laws and regulations. Valid Drivers License is Required Certifications Work...Full timePart timeWork experience placementWork at officeRemote workWorldwideRelocationVisa sponsorshipFlexible hours
- ...We are seeking a dedicated and knowledgeable Staff Water Operations Specialist to join our team. The successful candidate will be responsible... ...comfortable working both independently and as part of a team. A valid driver's license and the ability to work flexible hours may...Local areaFlexible hours
- ...Seasonal Operations Technical SpecialistThe seasonal Operations Technical Specialist supports the operational readiness of H&R Block's seasonal tax office network. This role ensures offices are fully equipped, functional, and aligned with brand standards by providing hands...Part timeSeasonal workWork at officeRelocationFlexible hours
- ...to learn and grow? We’re looking for an Associate Business Operations Specialist to engage in a role that directly supports JMP Business Operations... ...to support global sales business operations. Support validation of legal entity at a specific location with new and updated...Full timeLocal areaWork visa
- A leading engineering firm seeks a Staff Water Operations Specialist for its Cary, NC office. This role involves providing startup, commissioning... ..., and various benefits including a 401K match. A valid Driver's License is required, as travel may be up to 75%. #J...Work at office
- ...% Assist branch personnel with all system related questions. Basic Qualifications High school diploma or GED and 2 years of loan operations and bank systems experience or an equivalent combination of education and experience. Additional Qualifications Working experience...Work experience placementWork at office
$116.9k - $217.1k
...capability, digital connectivity and Operational Excellence converge to... ..., testing, qualification, validation, as well as all other... ...in line to meet product and cGMP/regulatory requirements. You... ...business improvement. Lead Specialists, and strategic leaders in the...For contractorsWork at officeLocal areaRelocation package- A community-focused organization is looking for an Operations Manager to take charge of both fieldwork and sales. This hybrid role involves leading a team in service tasks, optimizing daily routes, and making sales calls to build client relationships. The ideal candidate...
$76.23k - $93.62k
...public health to join our team. As a Water Treatment Plant Operations Specialist, you will be responsible for the technical, administrative,... ...talk, and smell. Special Requirements Requires possession of a valid driver's license with an acceptable driving record. Requires...Hourly paySeasonal workMonday to FridayShift work- ...description The Quality Assurance Specialist I is responsible for... ...meets both Kryosphere Standard Operating Procedures (SOPs), Client... ...Role and Responsibilities QA review incoming client material... ...QA review and approve validation documentation and other facility...Work experience placement
- ...Category/Area of Expertise: Retail Operations Job Requisition: 481626 Address: USA-NC-Fuquay Varina-3417 North Main St Store... ...seek to reduce costs and improve labor productivity • Follow QA daily check list and sanitation standards set by Food Lion • Follow...Local areaNight shift
- ...this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Operations Specialist Full-time Regular 3 days ago Requisition ID: 1036 Position Description At Cary Oil, our mission is to connect customers with...Full timeWork experience placementWork at office
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