FDA-Regulated Change Control Specialist
Jobtailor
Jobtailor seeks a Change Control Specialist to manage regulatory-compliant change control processes within FDA/cGMP frameworks. You will coordinate documentation, reviews, and approvals across plasma center operations and manufacturing teams. The role emphasizes attention to detail, strong communication, and the ability to work independently while prioritizing tasks to meet regulatory timelines in a fast-paced environment. #J-18808-Ljbffr Jobtailor
- Responsibilities Processes change control requests to ensure that process and documentation changes are thoroughly reviewed, justified... .... Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures...Suggested
$45 - $55 per hour
...5-55/hr Position Summary The Project Controls Specialist performs professional-level work requiring... ...detailed cost estimates for project changes and evaluate their impacts on total... ...capital projects. Experience supporting regulated or long-range capital planning...SuggestedContract workLocal area- ...People,\" join our team! Assist the Vice President of Lending Change Administration with the oversight of Loan Administration’s changes... ...lifecycle stages (Initiation, Planning, Execution, Monitor & Control, and Closing). The project meetings could include all levels of...SuggestedWork at officeLocal area
$45 - $60 per hour
...site integration, site delivery, and maintenance of projects and control systems. The ideal candidate will deploy distributed generation... ..., assets, switchgear, and controls/SCADA. Make field changes to support engineering and customer needs. Document final installation...SuggestedContract workTemporary workRemote work$57k - $74k
...Wednesday 8AM-6PM About This Role The Quality Control Associate II is responsible for... ..., a basic understanding of FDA/EMA regulations, effective interactions/communication... ...all, we work together to deliver life-changing medicines, with every role playing a vital...SuggestedTemporary workLocal area- ReNuke Services in Raleigh, NC seeks a Project Controls Cost & Scheduler I or II to support our client on complex initiatives. This full... ...You will generate periodic project controls analytics, manage change control, assist in WBS development, maintain cost and schedule...Full timeWork at officeLocal area
$95.86k - $208.27k
...pathways for growth. In this ever-changing market environment, our... ...currently seeking a Senior Specialist, IAM, SailPoint to join our... ...understanding of IAM processes, controls, and systems, notably... ...complies with all local/state regulations regarding displaying salary...H1bLocal areaNight shiftWeekend work- ...Grove Technologies, LLC, a dynamic and fast-growing federal contractor, is seeking highly skilled and motivated Program Control Analyst/Specialist to support operations in our Raleigh, NC office. The Program Control Analyst/Specialist is responsible for financial planning...Contract workFor contractorsWork at office
$93k - $171.3k
...the applicable independence regulations. In addition, you’ll collaborate... .../30/2026.Work you'll doAs a Specialist Manager, Engagement Matters... ...support awareness of new, changing, and existing independence... ..., risk assessment, internal controls, and interpretation of rules...Work at officeVisa sponsorship$114.1k - $268.18k
...pathways for growth. In this ever-changing market environment, our... ...is currently seeking a Lead Specialist, Cloud Security to join our... ...risk acceptance, compensating controls, renewals, reporting, and... ...complies with all local/state regulations regarding displaying salary...H1bLocal area- ...of the Patient Access Specialist is to leverage strategic... ...requirements per FDA, federal, and state level... ...for the handling of a controlled medication Work with stakeholders... .... Join our game-changing, global company... ...and municipalities have regulated paid sick time requirements...Local areaFlexible hoursNight shift
$103.95k - $180.53k
...evaluation, and improvement of air traffic control (ATC) systems by applying human factors... .... Prior experience working in regulated environments or government-sponsored engineering... .... Remote/hybrid status is subject to change based on Noblis and/or government...Full timeContract workPart timeWork at officeLocal areaRemote workWorldwideShift work$25 - $35 per hour
...Description The QC Sample Management Specialist plays a key role in supporting quality control testing by receiving, logging,... ...documentation standards in a regulated laboratory environment.... ...employment. Benefits are subject to change and may be subject to specific elections...Contract workTemporary workRelocationMonday to Friday- ...Field Safety Specialist The Field Safety Specialist ensures Adams... ...State and Federal applicable regulations are adhered to by the assigned... ...systems. Conduct quality control inspections of assigned field... ...responsibilities, and activities may change at any time with or without...For contractorsTraineeshipWork experience placementFlexible hours
$87.3k - $137.4k
...Support, Robotics, Machine Vision, Industrial Networks, SDLC/CSV, Change Control, GMP Documentation, Root Cause Analysis and Continuous... ...preferred). Knowledge of pharmaceutical, biotech, medical device or regulated manufacturing environments. Data Integrity, Cybersecurity,...For contractors- A leading construction firm in North Carolina seeks a Machine Control Specialist to manage GPS and machine control operations on heavy civil construction projects. The ideal candidate must have over 3 years of experience in the field, strong knowledge of Trimble systems...
$88k - $108k
Sr. Specialist, Compliance QA WHO WE ARE - Indivior is... ...company working to help change patients' lives by... ...inspections, managing Change Control and CAPA records, and... ...based on new regulations, guidance documents, industry... ...GMP/GXP as well as FDA trends and guidelines...Shift work$122k - $179k
Eaton’s Corporate Sector division is currently seeking a Power Electronics Control Specialist. The expected annual salary range for this role is $122000 - $179000 a year. Please note the salary information shown above is a general guideline only. Salaries are based upon...Local areaRelocation$35.87 - $51.57 per hour
...required structures. Appropriately controls radiographic equipment to... ...needs, alerts physician to changes in patient condition, and... ...products according to JCAHO regulations. Data Collection. Documents... ...and assigning work to other specialists and/or staff Operate, monitors...Hourly payFull time$81.4k - $151.2k
...ensure readiness for a step-change in the standard of care that... ...highly skilled Maintenance Specialist with direct Pharmaceutical Packaging... ...You will need to understand controlled, classified environments,... ...cGMP's, Health Authority regulations, and Quality Systems....Full timeWork experience placementWork at officeLocal areaFlexible hoursShift work- ...smiles.” Visit: Overview The QA Technical Specialist II performs final disposition of GMP... ...assessments for investigations, change controls, and supplier change notifications, and... ...and/or material control experience in a regulated manufacturing environment. Proven ability...Work at office
- control Systems Specialist Performs project startups, which includes instrument installation, calibrating, and commissioning; panel terminations, markups, and testing; network terminations and testing; and instrumentation and panel training. ESSENTIAL DUTIES AND RESPONSIBILITIES...Contract workFor contractorsWork at office
- As a result of our phenomenal growth, MSS Solutions, LLC has an opening for a Controls BAS System Specialist . If you are an experienced professional who is looking to grow your career and contribute fresh and innovative ideas to serve our customers, this is an opportunity...For contractorsFor subcontractor
- Inframark LLC is seeking a Control Systems Specialist to support startup, calibration, commissioning of instrumentation and control panels at project sites. You will perform wiring, testing, and field equipment interfacing, and provide customer training. Ideal candidates...
- ...A Day in the Life of an ACH Specialist At North State Bank, our ACH... ...compliance with NACHA rules, banking regulations, and internal policies.... ...returns, notifications of change, and payment issues. You... ...and maintaining operational controls. You review originator usage...For contractorsLocal areaDay shift
- ...stakeholders and have earned dozens of awards for project excellence, safety performance and as a best place to work. The Machine Control Specialist is responsible for managing and supporting GPS and machine control operations across all active heavy civil construction...For contractors
- Impellam Group is seeking a Project Controls Specialist II in Raleigh, NC, to support 1-2 project managers on varying projects. The role requires advanced knowledge of project controls and proficient use of control software tools. The position is full-time with a hybrid...Full timeWork at office
- State Employees' Credit Union is seeking a motivated individual to assist the VP of Lending Change Administration with overseeing Loan Administration changes and projects. The role includes preparing and implementing policy, guideline, procedure, and training updates for...
$81.5k - $138.55k
...a Lead Historic Preservation Specialist to provide regional leadership... ...order management, budget control, invoicing, schedule, personnel... ...resources scientists, planners, regulators, engineers, and other... ...complex challenges, navigate change, and shape the future. We can...Full timeContract workPart timeWork experience placementFor subcontractorWork at officeRemote workFlexible hours$35.36k
...future together. The Crown Is Yours As an Associate Quality Control Analyst, you'll join a passionate team dedicated to the sports... ...NASDAQ: DKNG) technology company headquartered in Boston. As a regulated gaming company, you may be required to obtain a gaming license...Hourly payPart timeImmediate start
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