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Jacobs
Severn, MD, United States
Welcome. You haven’t signed in yet so please select ‘I accept’ to start or access your Jacobs Career Application. My Account Options Implements and oversees quality control and quality control plans on contract within contract specifications and applicable industry standards. Responsible for generating and maintaining inspection procedures and st
Job Source: JacobsBarden
Dundalk, MD, United States
Barden are delighted to be supporting our Global Biopharmaceutical and Vaccine client in their search for a QA Lead for their state-of-the-art manufacturing campus in Dundalk. ABOUT THE ROLE: You will be responsible and accountable for ensuring GMP production quality system in place adhering to all regulatory, cGMP and company requirements, ensur
Job Source: BardenCatalent Pharma Solutions
Harmans, MD, United States
Catalent Pharma Solutions Supplier Quality Regional Lead Harmans , Maryland Apply Now Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to
Job Source: Catalent Pharma SolutionsDefense Contract Management Agency
Harmans, MD, United States
Summary See below for important information regarding this job. Additional vacancies may be filled from this announcement. Responsibilities Serves as a team leader for a quality assurance team, assigning work, providing feedback, checking progress, arranging training for team members, and providing input to supervisor. Reviews contracts to identify
Job Source: Defense Contract Management AgencyX-Bow Launch Systems Inc.
, MD, United States
Job Title: Program Quality Lead Engineer Company: X-Bow Systems Location: Indian Head, MD Position Type: Full-Time About Us: X-Bow Systems is a cutting-edge aerospace technology company focused on revolutionizing propulsion systems for space exploration and defense applications. Our team of innovative engineers and scientists is commit
Job Source: X-Bow Launch Systems Inc.Berry Global
Hanover, MD, United States
Berry Global LEAD QUALITY ASSR TECHNICIAN HANOVER , Maryland Apply Now Harnessing the strength in our diversity and industry-leading talent of 40,000+ employees across more than 250 global locations, we develop, design, and manufacture innovative products with an eye toward the circular economy. At Berry Global, we believe in the extr
Job Source: Berry GlobalMorgan Stanley
Baltimore, MD, United States
Morgan Stanley is a leading global financial services firm providing a wide range of investment banking, securities, investment management and wealth management services. The Firm's employees serve clients worldwide including corporations, governments, and individuals from more than 1,200 offices in 43 countries. As a market leader, the talent and
Job Source: Morgan StanleyHome Chef
Baltimore, MD, United States
Overview: Fulfills all responsibilities of a QC Tech, provides on the floor coaching for new and less experienced associates, and performs other duties such as packing, managing donations, and setting up, breaking down, and maintaining portioning equipment. QC Leads may assume additional responsibilities delivering training to QC Techs. Responsibi
Job Source: Home ChefDundalk, MD, United States
QA Lead - DS/DP Manufacturing
Our client, a global vaccine development and manufacturer are currently recruiting a QA Lead Drug Drug Substance Drug Manufacturing to join their team on a permanent basis. In this role, you will be responsible and accountable for ensuring GMP production quality system in place adhering to all regulatory, cGMP and company requirements, ensure all structures are in place to monitor, measure and ensure successful programme is applied. You will be responsible to ensure all necessary plans and standards are achieved consistently maintaining a high level of quality. Previous people management is required for this role. This is a 5 day per week on site role.
Responsibilities
Act as site QA responsible for on-site quality monitoring of DS/DP manufacturing and participant in GMP production activities, such as process transfer, validation etc
Close monitoring the construction quality of GMP production
Support CQV activities as necessary
Work with functional department to create department SOPs and assure alignment with corporate policies
Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective
Support site GMP Readiness preparation activities, including internal self-inspection programme
Responsible for establishing DS/DP QA team, including online support
Work closely with other teams, to support all GMP production activities
Perform routine audit for manufacturing area, to assure GMP production in compliance with all regulatory, market, EU, FDA and company standards
Review and approve manufacturing generated documents, including but not limited to qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, change control, QRM, etc
Ensure accurate reporting of manufacturing generated results and assure data integrity in daily activity
Manage a team of employees across QA for DS/DP. Ensure all associated performance management requirements are in place for each employee and relevant reviews are completed regularly
Ensure all relevant training is provided to employees who carry out DS/DP duties to ensure site SOPs are followed, accurate identification of deviations or any other quality issues
Liaise actively with cross functional teams for release DS/DP, including preparation of all documentation necessary for QP release
Other quality activities which supervisor assigns
Delegation of responsibilities to Sr. Specialist, QA for DS/DP
Requirements
Knowledge of legislative, regulatory, market, biologics and data integrity requirements
Preferable to have qualification Degree in Biopharmaceutical Science or other related science discipline
Relevant experience in vaccine/bio-pharma or similar experience in a pharma/science background
Strong communication skills with demonstrated ability to work in a matrix environment
Strong leadership competencies with demonstrated 5+ years management experience
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Email Alert for Quality Lead jobs in Dundalk, MD, United States
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