Summary
The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records. To succeed in this role, you will have a strong attention to detail and an analytical mindset.
Education:
Bachelors degree or equivalent
Experience Basic Qualifications:
1 year of relevant labeling experience in a cGMP/FDA regulated environment
• Some document management experience
• Crystal reports experience preferred
• Strong communication and customer service skills.
• Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
• Develop and improve label issuance processes to drive operational efficiency
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
• Possess project management skills.
• Experience interacting with FDA or other regulatory agencies strongly preferred
• Strong knowledge of cGMPs and domestic regulatory requirements
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
• Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network
DUTIES AND RESPONSIBILITIES:
• Supports all activities for the Quality Assurance Label Control group.
• Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
• Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
• Coordinates with production teams to ensure timely issuance of labels.
• Performs training of label control and issuance requirements for internal personnel as needed.
• Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
• Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
• Provides support during internal and health authority inspections and audits of facility.
• Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
• Performs supplemental investigations/projects as required by Management.
• Maintains knowledge of current GMPs and regulatory guidelines.
QA CTO Label Specialist • Summit, NJ
Claim Management Quality Insights Specialist.The Claim Management Quality Insights Specialist plays a pivotal role in elevating disability claims performance by conducting qualitative, pattern-base...[internal_linking.show_more]
The Materials Technical Support Specialist will utilize specialized knowledge and experience with Multivac materials and equipment to assist in the troubleshooting, isolation, and correction of pac...[internal_linking.show_more]
AlliedTravelCareers is working with Prime Time Healthcare to find a qualified CT Tech in Lafayette, Connecticut, 30327!.Now Hiring: Allied Healthcare CT - Lafayette, IN.Contact us for Pay Informati...[internal_linking.show_more]
Rexel USA is one of the largest distributors of electrical products, data communication, and related supplies in the United States.Rexel USA operates its electrical distribution business in the Uni...[internal_linking.show_more]
The Quality Assurance Specialist will provide quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support.You will manage CMO o...[internal_linking.show_more]
Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optim...[internal_linking.show_more]
Senior Quality Assurance Compliance Specialist, Qunol.Location: Pinebrook, NJ (hybrid).Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) &...[internal_linking.show_more]
Design outcome-driven content frameworks and AI workflows.Establish governance for AI-assisted content creation, retrieval, and usage.Define clear processes, metrics, and ownership to ensure operat...[internal_linking.show_more]
Taking care of our customers, our communities and each other.By honoring this commitment, we have maintained our reputation as one of the best property casualty insurers in the industry for over 17...[internal_linking.show_more]
Salary:$17 per hour none Reference:1132959-14 Job Description:Normal Work Schedule:5 days a week, 9 hours a day including 30-minute lunch and two 15-minute breaks.Evening and 3rd shift may be requi...[internal_linking.show_more]
At Concordance Healthcare Solutions, we believe that each team member makes a difference in driving our purpose of positively impacting lives forward.Concordance is committed to our guiding princip...[internal_linking.show_more]
Monroe Township, New Jersey, United States.About the Job Quality Assurance Specialist.Key Responsibilities - Support daily QA operations related to document control, change control, training, and C...[internal_linking.show_more]
Kosmos is the leader in passwordless authentication and identity verification, providing a unified platform that combines biometric authentication, identity verification, and lifecycle management.W...[internal_linking.show_more]
Livingston, NJ / New York, NY / Philadelphia, PA CoreWeave is The Essential Cloud for AI.Built for pioneers by pioneers, CoreWeave delivers a platform of technology, tools, and teams that enables i...[internal_linking.show_more]
AlliedTravelCareers is working with Prime Time Healthcare to find a qualified CT Tech in Lafayette, Connecticut, 30327!.Now Hiring: Allied Healthcare CT - Lafayette, IN.Contact us for Pay Informati...[internal_linking.show_more]
Specialist, Quality Assurance Documentation.A Specialist, QA Documentation will be responsible for the writing, distribution, collection, storage, and maintenance of our company's documentation.Thi...[internal_linking.show_more]
We are looking for a Quotations Specialist - Gear to join our Warshauer Electric Supply team in Parsippany, NJ!.Summary: Employee's level and pay will be dependent on their level of experience, kno...[internal_linking.show_more]
The Quality Assurance Specialist will provide quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA shop floor manufacturing support.You will manage CMO o...[internal_linking.show_more]
