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
Vacancy posted 10 hours ago
Similar jobs that could be interesting for youBased on the GMP Document Control Lead - Inspection Ready in Canton, MA vacancy
$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,...SuggestedTango Therapeutics
Boston, MA4 days ago- 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 areaEmergent Biosolutions
Canton, MA7 days ago$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 placementIntegra LifeSciences
Mansfield, MA10 hours ago- 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
CALLAHAN INC
Quincy, MA12 days ago $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 workIntegra LifeSciences
Braintree, MA10 hours ago- ...for on-site work in Boston to lead QA activities in support of clinical... ...while archiving essential documents in eDMS. The role emphasizes collaboration, audit readiness, and continuous improvement. The... ...cross-functional teams, strong GMP knowledge, and #J-18808-Ljbffr...Shift workDay shift
- ...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...
Integra LifeSciences
Braintree, MA15 days ago $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 areaGenentech
Boston, MA3 days ago$35 - $38 per hour
...filtration, aseptic filling, and visual inspection. The role supports equipment and material readiness, performs in-process checks, monitors and responds to alarms, documents impact assessments, and performs... ...The associate ensures accurate GMP documentation and works...Contract workShift workNight shift- ...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$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- ...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...
Katalyst Healthcares & Life Sciences
Boston, MA10 hours ago - ...Therapeutics is seeking a Manager, GxP Document Control to oversee and continually improve document... ...quality systems coordination. You will lead cross-functional teams to balance speed,... ...authors and reviewers on clear, audit-ready procedures. The role is based in our Boston...Work at office3 days per week
- Vertex Pharmaceuticals LLC is seeking a GMP Operational Quality Senior Specialist Contractor to support quality... .... The role focuses on investigations, CAPA, change control, and timely batch release. The candidate will lead quality metrics, root-cause analysis, and risk...For contractors
- BJ’s Wholesale Club, Inc. is hiring a Meat Lead in Stoughton, MA to oversee meat department operations, ensuring food safety, managing... ..., labeling accuracy, data analysis for improvements, and performing routine inspections. #J-18808-Ljbffr BJ's Wholesale Club, Inc.
- ...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...
- ...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...
- ...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
$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 workSenior plc
Sharon, MA3 days ago$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 payAmerican Family Care
Brockton, MA10 hours ago$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 hoursGecko Robotics
Boston, MA25 days ago$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 shiftBoston, MA11 days ago$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 areaH&H
Boston, MA23 days ago- ...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
Torito Brands
Quincy, MA3 days ago $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 areaWorldwidePuma
Boston, MA3 days ago$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 shiftWSP Group
Boston, MA4 days ago$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 homeModerna Therapeutics
Norwood, MA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to GMP Document Control Lead - Inspection Ready. Be the first to apply!
Related searches
- document technician Canton, MA
- document Canton, MA
- document manager Canton, MA
- document processing Canton, MA
- document analyst Canton, MA
- document control coordinator Canton, MA
- document review analyst Canton, MA
- document control manager Canton, MA
- inspection coordinator Canton, MA
- electrical inspection Canton, MA