Job description

QA LABEL SPECIALIST - 3RD SHIFT
SUMMIT, NJ

Schedule: Wed-Sat 8:00 pm-6:00 am (3rd shift)
100% onsite.

Duration: 6+ months (high possibility of extension for the right candidate)

Required Skills:

• Bachelor's degree or equivalent degree.
• Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
• Some document management experience.
• 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.
• To succeed in this role, you will have a strong attention to detail and an analytical mindset.
• 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.

Project Description:

• 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.
• 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.

This 6+ month position starts ASAP.

ALPHA'S REQUIREMENT #23-00802
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Type: Contract

Salary: $43.00 - $46.00 per hour

Schedule:

• 10 hour shift

Work setting:

• In-person

Work Location: In person

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