QA LABELING SPECIALIST

QA LABELING SPECIALIST - Pay Rate $46/Hour

The Quality Assurance Document Control (QADC) Labeling Specialist will be responsible for supporting the cGMP Document Control operations for the client site. This includes coordinating, issuing, reconciling, and managing production labels and records. The successful candidate will possess strong attention to detail, an analytical mindset, and a willingness to work collaboratively with cross-functional departments.

Key Competencies:

• The ideal candidate will have a Bachelor's degree or equivalent and a minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment. The following competencies are required for this position:
• Strong communication and customer service skills
• Ability to prioritize, manage time well, multi-task, and troubleshoot effectively
• Innovative, proactive, and resourceful
• Possess project management skills
• Knowledge of cGMPs and domestic regulatory requirements
• Knowledge of manufacturing quality
• Ability to work independently and communicate with the manager on decisions outside of established processes
• Experience interacting with FDA or other regulatory agencies strongly preferred
• Crystal reports experience preferred
• 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)

The QADC Labeling Specialist will be responsible for the following duties:

• Supports all activities for the Quality Assurance Label Control group
• Issues clinical and commercial in-process and final product labels for labeling operations
• Ensures 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, 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
• Performs supplemental investigations/projects as required by Management
• Maintains knowledge of current GMPs and regulatory guidelines

Working Conditions: The QADC Labeling Specialist 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.

• 1st Shift Sun-Wed 1pm to 11pm
• 2nd shift Wed- Sat 1pm -11 pm
• 3rd Shift Wed-Sat 5:45am to 3:45pm

If you are interested in this opportunity APPLY TODAY!

Thank You, I look forward to connecting with you!