Manufacturing Deviations Specialist

Deviations Specialist (Pharmaceutical)Boston (Seaport), MASummaryDPS Engineering is looking for a Manufacturing Deviations Specialist to provide investigation and compliance support to the Pharmaceutical Manufacturing Facility. The ideal candidate will perform complex root cause analysis, work with stakeholders to identify corrective and preventative...

Job Description General Summary: Vertex Pharmaceuticals Inc. has established a state-of-the-art GMP manufacturing facility in Boston less than a mile from the Corporate Headquarters in the Seaport District. This GMP facility is a keystone to delivering our strategy of bringing transformative medicines to patients in need, from clinical development to...

Position Summary The Quality Assurance Specialist will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and manufacturing processes to contract manufacturing organizations including technology transfers within the External manufacturing realm. The Quality Assurance Specialist...

ABOUT ELEKTROFI Elektrofi is a biopharmaceutical formulation technology company that is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated...

SummaryDPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site.ResponsibilitiesPerform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA site.This quality...

SummaryDPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site.ResponsibilitiesPerform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA site.This quality...

**Job Description**: **JOB DESCRIPTION**: **KEY RESPONSIBILITIES**: May include, but are not limited to, the following: - Identifies and supports quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and...

Manufacturing Process Scientist, Drug Product ManufacturingBoston, MAOur client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will author/review documentation for late-stage process development activities and work cross-collaboratively to identify gaps and add...

Responsibilities: Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices. Provide statistical analysis of the date to support the reports. Generation and implementation of change controls and engineering notices (ECO). ...

Job Description General Summary: The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition. * This is an on-site position on the 2nd...

Job DescriptionJob Description Job Title: GMP Operational Quality Sr Specialist Location: Hybrid Boston Salary range: $50-60/hr Nice to have qualifications: · Provides QA review of the GMP data in support of release of commercial product as required. · Collaborates with internal and external business partners to resolve quality issues to ensure compliant...

Sr Specialist, Quality AssurancePosition Summary The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing protocols, methods, reports and...

Job DescriptionJob DescriptionSr Specialist, Quality AssurancePosition Summary The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing...

Sr Specialist, Quality AssurancePosition Summary The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing protocols, methods, reports and...

Job Description General Summary: The Director, Manufacturing Technical Services, Quality Assurace is responsible for the quality oversight of Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTOs) for Cell & Genetic Programs through the lifecycle development process. This includes quality oversight for the selection, qualification and...

Our client, a well-known firm, is seeking an Operation Specialist to join their growing team. Responsibilities: Processing checks, wires, ACH payments, transfers and receipts. Maintenance of all recurring cash items. Reconciliation of cash balances a Operations Specialist, Operations, Specialist, Processing, Manufacturing, Staffing

Company Overview Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central...

About the Office of the Comptroller The Office of the Comptroller ensures that the more than $50 billion in annual transactions authorized by the general appropriations act and supplemental appropriations are executed in accordance with all statutory Support Specialist, Operations, Operations Coordinator, Support, Program Coordinator, Specialist,...

Description We're looking for a Compliance Specialist I , working in Pharmaceuticals and Medical Products industry in 500 Soldiers Field Road, Boston, Massachusetts, 02134, United States . Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation. Conducts internal audits...

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices...