CTO QA Label Specialist at Sunrise Sysytems Inc

Job Title: CTO QA Label Specialist
Job ID: 24-04548
Location: Summit, NJ, 07901
Duration: 06 Months contract on W2

This is a 100% onsite position.
This position is scheduled for Wed-Sat (6:30 am -4:30 pm).

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 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.

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.