GMP Compliance Investigator: Equipment & Facilities Expert
Eight Eleven Group
Medasource seeks a GMP Compliance Investigator – Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. This hands-on role leads investigations, authors quality documentation, and partners with Manufacturing and Quality teams to ensure FDA and accreditation standards are met.
You will develop SOPs, manage deviations, CAPAs, and change controls; author IQ/OQ/PQ validation documents; and assist during inspections.
#J-18808-Ljbffr- ...activities by operating production equipment, executing batch records, and maintaining compliance with GMP standards while ensuring... .... Support deviation investigations and corrective actions. Maintain... ...Experience working in GMP-regulated facilities. Familiarity with electronic...EquipmentFacilitiesRemote workShift work
$98.7k - $183.3k
...the reliability and compliance of the equipment and systems that support... ...support for GMP manufacturing equipment, utilities, facilities, and a broad range of... ...across site operations.Investigate equipment and process... ...as a subject matter expert during FDA inspections...EquipmentFacilitiesFull timeRelocation package- ...manufacturing at the assigned GMP Manufacturing facility.Assists and supports the... ...with initial compliance and ongoing preparation,... ...maintenance of scientific equipment and instrumentation, computer... ...events (such as Laboratory Investigations) in the quality systems,...EquipmentFacilitiesFull time
$108.5k - $201.5k
...environment. Working within a GMP-regulated facility, you'll drive automation... ...projects that strengthen compliance, operational efficiency,... ...integration of packaging equipment and serialization technologies... ...within GMP manufacturing.Investigate automation-related non-...EquipmentFacilitiesFull timeFor contractorsWorldwideRelocation package- ...Technician manages laboratory equipment calibrations,... ...repairs, ensuring compliance with all GxP regulations... ...of deviation investigations related to metrology.... ...USP, NIST, FDA, GLP, GMP). \n \n Safety and... ...Systems Validation, Facilities and Engineering, and...EquipmentFacilities
- ...ManagerJob Summary: The Maintenance Manager leads facility upkeep, ensuring efficient operations, regulatory compliance, and continuous improvements. This role... ...Managing repairs, upgrades, and vendor coordination.Equipment & Systems Knowledge – Expertise in mechanical systems...EquipmentFacilities
- ...supporting new manufacturing sites, facilities expansion, utilities, equipment, and related systems. This role... ...schedule in a state of readiness for GMP operations, while meeting Abbvie quality... ...of systems for GMP operations in compliance with applicable regulatory, quality...EquipmentFacilitiesFor contractors
$130k - $146k
...Facilities Electrical Area Manager | Permanent | On-Site | Durham... ...systems and facility equipment • Ensure compliance with all applicable electrical... ...• Lead root cause investigations and corrective action initiatives... ...and technical teams • Expert knowledge of industrial...EquipmentFacilitiesPermanent employmentFull timeFor contractors$96.2k - $151.4k
...internal manufacturing facilities, external... ...qualification of equipment, facility and utilities... ..., and GMP requirements.General... ...applies regulatory/ compliance requirements relative... ...controls, and investigations for the performance... ...a subject matter expert.Makes decisions...EquipmentFacilitiesFull timeContract workFor contractorsLocal areaFlexible hoursAfternoon shift$130k - $146k
...Job Description Facilities Electrical Area Manager | Permanent... ...systems and facility equipment \n • Ensure compliance with all applicable electrical... ...\n • Lead root cause investigations and corrective action... ...and technical teams \n • Expert knowledge of industrial electrical...EquipmentFacilitiesPermanent employmentFull timeFor contractors$146k
...Facilities Electrical Area Manager PERM Full Time Durham... ...energy efficiency, regulatory compliance, and long-term facility... ...electrical systems and facility equipment in collaboration with project... ..., and technicians. • Expert knowledge of electrical power...EquipmentFacilitiesPermanent employmentFull timeFor contractors$98.7k - $183.3k
...the reliability and compliance of the equipment and systems that support... ...support for GMP manufacturing equipment, utilities, facilities, and a broad range of... ...site operations. Investigate equipment and process... ...as a subject matter expert during FDA inspections...EquipmentFacilitiesFull timeRelocation package- ...as required to ensure patient safety in the facility.Participate in restraining combative patients as necessary.Ensure compliance with safety and infection control... ...but not be limited to tidying room, cleaning equipment, changing bed linens, restocking work areas...EquipmentFacilitiesImmediate start
- ...damages, markdowns, scanning, paperwork, and facility controls.Ensures the financial integrity... ....Ensures that the store is adequately equipped with tools necessary to perform required... ...communications; ensures employee compliance.Completes all paperwork and documentation...EquipmentFacilitiesSeasonal work
- ...treat and test systems for environmental compliance, and engage the public in water... ...crews performing basic and complex labor, equipment operation, construction, maintenance, and... ...motors, gearboxes, and other equipment and facility components; and fabricatesInspects, tests...EquipmentFacilitiesFull timeTemporary workPart timeWork at office
- ...maintenance, troubleshooting, and repair of critical facility assets Lead and control changes to utility and facility equipment to maintain validated and qualified system... ...corrective actions Ensure ongoing compliance with good manufacturing practices, Code of Federal...EquipmentFacilitiesFull timeContract workWork experience placement
- ...management of the batch release process. Assist the facility in preparation for quality audits and... ...Experience providing QA support and oversight of GMP manufacturing operation Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with...FacilitiesWork at office
- ...diagnostic and therapeutic facilities, including a regional emergency... ...clinical patient care and compliance with administrative and clinical... ...development from novice to expert to positively impact on... ...maintenance of unit inventory, equipment and supplies. Coordinate the...EquipmentFacilitiesRelocation package
- ...warehouse operations at its Durham, North Carolina facility. This role manages facility efficiency, staffing, compliance, and cost control while serving as a liaison... ...facility operation, cost-effectiveness, and equipment utilization Monitor work volumes and adjust...EquipmentFacilities
- ...coverage as required to ensure client, vendor, and guest compliances to company policies, procedures, and guidelines.Oversee office... ...operations, ensuring efficiency by managing supplies, equipment, and facilities.Coordinate and oversee office maintenance, repairs, cleanliness...EquipmentFacilitiesWork at office
- ...critical raw materials, manufacturing equipment, production services, and strategic suppliers... ...Collaborate with Logistics and Trade Compliance to optimize transportation, customs... ....S. Person due to required access to U.S. export-controlled information or facilities....EquipmentFacilitiesPermanent employmentContract workWork experience placement
$61.03k - $88.43k
...support food safety, quality assurance, facility readiness, and exceptional customer experiences... ...food safety, sanitation, regulatory compliance, and quality assurance programs. Conduct... ...service concerns. Support Facilities, Equipment, and Asset Management Coordinate...EquipmentFacilitiesTemporary workFor contractorsWork experience placement- ...diagnostic and therapeutic facilities, including a regional emergency... ...dispensing systems; ensure compliance with Federal, State and... ...education and oversight for investigational medications for patients;... ...systems, automated and technical equipment. Ability to establish and...EquipmentFacilitiesReliefLocal areaWeekend workAfternoon shift
- ...part in ensuring regulatory compliance, system efficiency, and environmental... .... Serves as a technical expert, leads troubleshooting... ...control and procurement of equipment, supplies, and chemicals. Assists... ...of wastewater treatment facilities. Thorough knowledge of chemical...EquipmentFacilitiesWork at officeLocal areaRotating shift
- ...Hospital for Special Surgery5 Star CMS rated facility for patient experiencePositive Work... ...area procedures and protocols.Demonstrates compliance with state, federal/CLIA and accrediting... ...sufficient inventory of supplies and equipment needed for performance of duties.Utilize...EquipmentFacilitiesRelief
- ...within a team environment. Responsibilities: Clean and maintain GMP facility Follow standard operating procedures (SOPs) and adhere to safety protocols at all times. Sanitize equipment Stock essential items of PPE gear (gloves, gowns, eyewear) Comfortable...EquipmentFacilities
- ...premier Bio/Pharma manufacturing facility in RTP. Serving as an... ...gap between technical safety compliance and daily plant floor operations... ...SOPs. Conduct equipment walkdowns, analyze technical... ...assist with incident root-cause investigations. Provide safety training...EquipmentFacilitiesHourly payFor contractorsLocal area
- ...supply chain management, quality system compliance, and cross-functional coordination with... ...with technical leadership on equipment expansion decisions and production capability... ...qualification processes. Ensure all facilities meet regulatory compliance, safety standards...EquipmentFacilitiesContract workWork experience placement
- ...United States, with passionate, local experts collaborating with farmers to... ...Unit (QAU) is committed to ensuring compliance with the EPA FIFRA Good Laboratory... ...for monitoring studies and facilities to ensure the facilities, equipment, personnel, methods, practices, and...EquipmentFacilitiesContract workWork at officeLocal areaFlexible hours
- ...Finish Expansion Project at their greenfield facility. These engineers will support the... ...troubleshooting of automated assembly and packaging equipment within Finished Products buildings. The... ...IT/OT integration in a highly regulated GMP environment. REQUIRED SKILLS AND...EquipmentFacilitiesFull time
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