GMP Document Control Lead - Inspection Ready
Emergent Biosolutions
Emergent BioSolutions in Canton, MA, seeks a QA Specialist I, Document Control to own the GMP document control program for the vaccine Drug Substance site. You will govern controlled documents, ensure GDP/ALCOA+ compliance, and serve as the EDMS SME to support inspection readiness and regulatory alignment. You will lead doc control workflows, archiving, deviations, CAPAs, and KPIs to drive continuous improvement and robust data integrity across the site. #J-18808-Ljbffr Emergent Biosolutions
$151.2k - $226.8k
...to ensure processes, document control, training, and quality... ...harmonization across GxP domains (GMP/GLP/GCP) and alignment... ..., traceable, audit-ready, and meet data... ..., training compliance)Lead QMS simplification/optimization... ...QMS-related inspections and audits QMS design,...Suggested- Moderna is seeking a scientific lead in Analytical Development to transfer and implement... ...and QC laboratories. You will assess readiness, design transfer strategies, and work with... ...methods are reproducible and compliant with GMP and regulatory expectations. This role...Suggested
$84k - $101.7k
...Emergent is a leading public health company... ...supporting the overall GMP manufacturing... ...Manufacturing. Own document revisions and... ...implementation of change controls. Executes... ...the area is audit ready at all times.... ...audits and regulatory inspections. The above...SuggestedLocal area$109.25k - $149.5k
...standards of care.SUMMARYThe Lead Auditor, Quality Compliance will... ...with recognized ISO, GMP, GDP, GCP, and GLP, global policies... ...improving audit standards, inspection readiness, SME coaching, and reviewing... ...retaining the same levels of quality control.Facilitate Global...SuggestedFull timeTemporary workWork experience placement- Moderna is seeking a QC Raw Material professional to perform release and inspection activities for GMP manufacturing. The role emphasizes cGMP documentation, risk assessments, and collaboration with internal and external labs on methods like HPLC and TruScan. Responsibilities...SuggestedShift work
- ...Description Summary/Objective : The Lead Superintendent oversees the full scope... ..., QA/QC, Subcontractor Management, Document Control, Schedule, Relationship Management & Project... ...of the Safety Manager Manage safety inspection reports, verify remediation has...Contract workFor subcontractorWeekend work
$34.28 - $47 per hour
...of care. The Lead Facilities Maintenance... ...operates in a GMP-regulated environment... ..., manage change controls, and address deviations... ...Asset documentation Maintain accurate... ...Conduct safety inspections and enforce safe work... ...ensure regulatory readiness (e.g., fire systems...Hourly payTemporary workFor contractorsLocal areaShift workWeekend work- ...experienced Laboratory Operations Leader for the Chemistry Center to provide strategic and operational direction, ensuring GMP readiness and inspection preparedness. You will oversee LIMS, CSV, CQV activities and drive continuous improvement across laboratory operations....
- ...Lead Auditor for Quality Compliance at Integra LifeSciences will direct internal audits... ...audits, evaluating compliance with GMP and ISO standards, and serving as a subject... ...broader organization Support regulatory inspection readiness through audits, mock inspections, and...
$136.4k - $253.2k
...Analytical Data Science is recognized as a leading hub for top industry talent, operating... ...the TA leadYou ensure compliance and inspection readiness by establishing robust quality review processes, maintaining thorough documentation, and proactively addressing potential...Full timeLocal area$63.2k - $100.9k
...downstream visual inspection. This role ensures... ...material and component readiness, performs enhanced in-process controls, and keeps... ...parameters while documenting contemporaneously... ...experience. 2-4 years in GMP manufacturing or... ...to build the leading mRNA technology platform...Permanent employmentWork from homeNight shiftWeekend work- ...filtration, aseptic filling within isolators, and visual inspection. You will ensure material readiness and contemporaneous MES/eBR documentation, enabling compliant production. The role requires 2-4 years of GMP manufacturing experience or entry-level with training, and...Night shift
$63.2k - $100.9k
...downstream visual inspection. This role ensures... ...material and component readiness, performs enhanced in-process controls, and keeps... ...parameters while documenting contemporaneously... ...experience. 2-4 years in GMP manufacturing or... ...aspired to build the leading mRNA technology...Permanent employmentWork from homeNight shiftWeekend work- ...Reference26-00544Job Summary: Responsible for leading and maturing the Validation / Computer... ...compliance gaps, supporting audit readiness, and overseeing validation activities across... .... Prepare for FDA audits and support inspection readiness activities. Oversee validation...
- ...role focuses on analytical methods for excipients, raw materials, and process-related impurities, with strong emphasis on regulatory readiness and method lifecycle management. The ideal candidate has 7+ years in analytical method development or 5+ years with a Master’s,...Contract work
- ...ensures compliant testing of raw materials, in‑process, finished products and stability samples, with data integrity and regulatory readiness. You will supervise daily lab operations, oversee method performance and instrument status, mentor staff, review records, manage...Contract work
- ...States seeks an Analytical Sciences transfer lead to drive method moves from development... ...and QC laboratories. You will oversee readiness assessments, strategy design, and cross-site... ...in analytical method transfer, GMP environments, and strong troubleshooting...
- ...oversee QA/QC, investigations, CAPAs, and change controls to ensure final product safety and efficacy for FDA and state boards. You will lead audits, trainings, and regulatory... ...and team development to maintain top-tier GMP standards and ongoing improvements. #J-188...
$80k - $100k
...precision manufacturing environment by leading daily operations across machining and inspection. The Production Supervisor is... ...Bigger With Us. If you're ready to roll up your sleeves, make things... ...of chargeability for export control purposes. Additionally, potential...Permanent employmentTemporary workFor contractorsImmediate startShift work$27 - $31 per hour
...team. We're looking for an experienced Lead Medical Assistant to set the standard... ...including DOT physicals Run lab quality controls and keep daily logs and checklists... ...expiration dates) so the clinic is always inspection-ready Keep exam rooms, supplies, and...Hourly pay$170k - $240k
...wall-climbing robots, industry-leading sensors, and an AI-powered... ...operations, promote mission readiness, and protect the environment... ...regular access to export-controlled technical data, U.S. Government... ...Understanding of structural inspection, corrosion, or lifecycle...Permanent employmentWork at officeLocal areaWork from homeFlexible hours$23.04 - $31.7 per hour
...small team under the direction of the site lead and/or supervisor, enabling the team to... ...programs such as hazard identification, conduct inspections and incident reporting/investigations as... ...or related experience required GMP experience and/or demonstrated competency...Hourly payFull timeTemporary workWork at officeMonday to FridayShift workNight shiftDay shift$110k - $165k
...Job Description Job Description We are offering an exciting opportunity for an Bridge Inspection Group Manager/Team Lead to join our Boston office. We are seeking an Inspection Group Manager/Team Lead to join our Boston office. This role involves leading and overseeing...Work at officeLocal area- ...Supervisor is responsible for leading daily packing... ...single day shift, enforces GMP and SQF protocols, and... ...coaching and documented corrective action •... ...audits and pre-operational inspections; close findings before... ...implementation • Ensure allergen control, sanitation, and pest...Hourly payFull timeContract workTemporary workShift workDay shift
$99.2k - $134.68k
...needs for employees and visitorsEnsure daily facilities inspections are conducted and documented, confirming all safety, security, and emergency preparedness... ...on space planning with department and senior leaders; lead and project manage office renovations, installations,...Full timeContract workFor contractorsWork at officeLocal areaWorldwide$90.6k - $150.59k
...initiating a search for an Ancillary Inspection Team Leader to join our... ...proposals and scope of work documents. Assist in collecting and... ...company of WSP, one of the world's leading engineering and professional... ...and challenges. Are you ready to get started?WSP USA (and all...Work at officeLocal areaRelocation packageFlexible hoursNight shift$142.5k - $256.5k
The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory... ...product development projectsReview documents for submission-readiness, to ensure that all submissions... ...****@*****.***. Export Control Notice This position may involve...Permanent employmentFull timeWork at officeWork from home- ...ResponsibilitiesThe Trenchless Geotechnical Team Lead will report to the Trenchless Services... ....Perform data management and quality control of geological data.Aid in geotechnical... ...performing trenchless construction oversight and inspection. As well, strong written and verbal...For contractorsLocal areaRemote work
$115k - $170k
...Bridge Inspection Team Leader/Manager Job Locations US-MA-Watertown... ...of and shape an industry-leading inspection program across our... ...field notes, assembling record documents, and generating inspection reports... ...as a great place to work. Ready to shape what's next? Learn...Full timeWork experience placementWork at officeFlexible hoursNight shift$18.5 - $23.5 per hour
...required cash handling, and ensuring the floor and stock room are ready for the business day. Responsible for opening back door of... ...Preferred Qualifications Prefer the knowledge of store inventory control. We will consider employment of qualified applicants with...Hourly payWork experience placementSeasonal workLocal areaShift work
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