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- A leading Contract Research Organization is seeking a Product Complaint Manager to oversee the Product Complaint Quality System. This role involves managing complaint-related activities, conducting investigations, and collaborating with cross-functional teams. Candidates...SuggestedContract work
$65 - $69 per hour
A leading biotech firm is seeking a Senior Specialist in Manufacturing Technical Operations based in Boston. This role is crucial for managing quality records related to cell manufacturing, including deviations and change controls. The candidate will lead investigations...SuggestedHourly pay- ...product development cycle management to the existing platform. You will work closely with Quality and Regulatory on complaints, NCRs, CAPAs, and field investigations while ensuring the device meets reliability, manufacturability, and compliance expectations. Key...SuggestedFull timeContract work
- ...equipment performance, reliability & continuous improvement initiatives Drive troubleshooting, root cause investigations, deviations & CAPAs Collaborate cross-functionally with Manufacturing, Quality, MS&T & Engineering teams Requirements 10+ years pharmaceutical...SuggestedContract work
$65.5k - $87.5k
...packaging of reagents and final product. May participate in the investigation, recording and implementation of product deviations or CAPA systems. May participate in transfer and implementation of new products into the production lab. May perform functional assays...SuggestedFull timeTemporary workPart timeWork at officeLocal areaRelocation- ...protocols, and reports; reviewing, analyzing, and trending data; managing quality records such as investigations, change controls, and CAPAs; training and mentoring analysts; and maintaining a safe laboratory environment. The ideal candidate holds a BA/BS degree in a STEM...SuggestedContract work
- ...background. Must have extensive experience in a Quality Assurance role supporting complaint management and root cause investigations / CAPA development in at least one of the following areas: device, biologics or small molecule. Understanding of industry standards and...SuggestedContract workWork experience placement
$70k - $75k
...align digital strategies with institutional goals. Collaborate across departments including Admissions, Development, Academic Affairs, CAPA, and NECO’s two clinics. Manage multiple projects simultaneously, meeting deadlines in a fast‑paced academic environment. Assist...SuggestedTemporary workWork at officeRemote work$116.9k - $175.3k
...and ensure best practices are implemented Manage projects related to documentation, training, or electronic systems Own deviation, CAPA and Effectiveness Check (EC) and Change Control (CC) records in electronic Quality Management System (eQMS) and drive to completion...SuggestedSummer workWork at officeFlexible hours- ...international regulatory frameworks. Experience with QMS implementation and ISO 13485. Experience with risk management, design controls, CAPA, document control. Ability to collaborate with engineering and operations in a fast moving environment. Required Regulatory...SuggestedFull timeWork at officeFlexible hours
- ...with non-functional testing areas, including performance, stress, and scalability testing Exposure to quality methodologies such as CAPA (Corrective and Preventive Actions), 8D Problem Solving, or Six Sigma Ability to contribute to test strategy documentation and...SuggestedSummer workCasual workWork at officeRemote workWork from home
- ...of successful pilots AI Use Case Delivery Partner with business stakeholders to define high‑value AI use cases (e.g., deviations, CAPA prediction, batch analytics, document intelligence) Oversee model development lifecycle (data readiness, training, validation, deployment...SuggestedRelocation packageFlexible hours
$118.4k - $177.6k
...includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS. Ensures appropriate CAPA actions are identified and addressed. Approves investigations/CAPAs. Identify, facilitate, and/or lead continuous improvement...SuggestedWork experience placementSummer workRemote workFlexible hours2 days per week$100k - $120k
...data to identify trends, prioritize investigations based on business value, and develop clear, actionable corrective action plans (CAPAs).**Our team did the testing to ensure Form 4 would be the most reliable printer Formlabs has ever built:*** **LCD & Light Engine:**...SuggestedFull timeWork at officeWorldwideFlexible hours$71.1k - $112.5k
...ARVETO 3PL, Oracle Transportation, Global Trade Management, and Oracle EBS. Experience in risk‑based validation, deviation handling, CAPA management, and process harmonization. Strong leadership and stakeholder management skills across geographies and time zones....SuggestedTemporary workWork at office3 days per week$86.4k - $93.2k
...required. Provide oversight and management of internal CMCF audits and select external audits. Participate in root cause analysis and CAPA (corrective and preventative action) plans. Participate in review of validation plans and completed validations. Assist in...Work at office- ...are being delivered, including ownership of smaller initiatives. Gather documentation for quality related activities as necessary (CAPAs, deviations, change controls). File documents in eTMF and conduct PQCs. Possibility of quarterly travel to Client Boston...Contract workWork at officeRemote work
$186.67k - $251.07k
...Manage Safety vendors to ensure compliance with agreements and KPIs. Identify and manage Third Party quality events, associated CAPAs, and further process improvements. Maintain and monitor global SUSAR compliance metrics. Maintain Blind across all individual...Full timeContract workWork experience placementRemote work- ...comply with cGMP, GCP, GDP, and global regulatory requirements; partner with Quality on batch release, deviations, investigations, CAPAs, and change controls; support regulatory submissions with supply chain documentation. Cross-Functional Leadership: Act as a core member...Local area
$153.6k - $241.34k
...improve the global risk-based supplier audit program. Conduct supplier audits end-to-end, including planning, execution, reporting, and CAPA follow-up. Assess and re-evaluate supplier risk categories, audit frequencies, and key risk indicators. Monitor and report...Minimum wageFull timeTemporary workLocal area$265k - $300k
...specific documents. Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management. Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and...Work at officeRemote work$235k - $295k
...inspections and submissions (IND, CTA, NDA, MAA) Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes. Identify, track, and manage CAPAs arising from audits, inspections, deviations, and...Full timeContract workWork at office3 days per week$61.7k - $75.6k
...complex documentation like logbooks. May revise procedures under direct supervision. May participate in investigations. May execute CAPA tasks. Identify and implement small continuous improvement projects. Responsible for assigned production activity and ensuring...Work experience placementShift workAfternoon shift- ...PQR), and ongoing process monitoring. Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports. Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS...Work at officeRemote workWork visaFlexible hours
$79.56k - $115.72k
...procedures. Review CTTL staff’s training and competencies Review and investigate occurrence/safety/incident reports and conducts RCA/CAPAs as needed. Participate in site initiation visits (SIV) and collaborate with Research Team on research study site initiation forms,...Work at officeLocal areaRemote workShift work- ...procedures. Trend analysis on complaint data, identifying emerging safety issues and initiating corrective and preventive actions (CAPA). What We Look For Bachelor’s degree in engineering, biomedical engineering, or scientific field, or equivalent industry experience....Flexible hours
- ...FDA regulations) and Hemab’s quality standards Author clear, actionable audit reports and track corrective and preventive actions (CAPAs) through to effective closure Maintain the audit schedule and adjust plans based on emerging risks, programme milestones, and regulatory...
$41.38 - $100 per hour
...; AORN certification preferred. PACU/Henderson: 2 years critical care/PACU experience; ACLS, PALS required within first year; CPAN/CAPA preferred. Pediatrics: 2 years Pediatrics experience; NRP required within first year if cross‑trained. Pedi GI: 2 years Pediatric...Hourly payRemote workShift workNight shiftWeekend work$205.19k - $328.3k
...Prevention Control to provide DU expertise pertaining to risk management, design controls, health hazard assessments, complaints assessment, CAPAs, nonconformances, and benefit risk determinations. GI Leadership Team: Serve as a member of the GI Business leadership team to...Full timeLocal areaRemote workWorldwideAfternoon shiftEarly shift$71.25k - $161.7k
...implementation of tech transfer, qualification and documentation. Support OOS, OOT, investigations, deviations, change controls and CAPAs pertaining to the QC laboratory. Maintain laboratory equipment and perform routine cleaning. Engage in laboratory audits. Receive...Permanent employmentFull timeH1bWork at officeVisa sponsorshipWork visaFlexible hours