QA Label Specialist
Dexian - Summit, NJ
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Job Description: Job Title: CTO QA Label Specialist/Quality Label Specialist Location: Summit NJ 07901 * 100% OnsiteSchedule: Wed-Sat (6:30 am -4:30 pm)Duration: 06 Months (Extendable) Job Description: The Quality Assurance Label Control (QALC) Labeling Specialist supports the cGMP Label 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. REQUIRED COMPETENCIES: Education:Required bachelor's degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment Experience Basic Qualifications:• Minimum of 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 the FDA or other regulatory agencies is 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 the manager on decisions outside of established processes and the ability to build an internal network. DUTIES AND RESPONSIBILITIES: Primary responsibilities include:• 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 markets, and other quality management activities as assigned.• Provides support during internal and health authority inspections and audits of the 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. WORKING CONDITIONS (US Only):• Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts. - Weekend and off-shift support may be required. - Occasional lifting of heavy weights up to 25 to 35 lbs.Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexians platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.Dexians brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more.Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
Created: 2024-10-13