QA Label Control Specialist- Pharma (Onsite- Summit, NJ)

We are seeking a QA Label Control Specialist- Pharma (Onsite- Summit, NJ) for a global pharmaceutical client. You will be responsible for supporting site Label Control activities at S-12 in accordance with client's policies, standards, procedures and Global cGMPs. Functional responsibilities include performing in process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO). Label Control organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives.

This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite role in Summit, NJ.

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

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

Responsibilities:

• Supports all activities for the 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.

• Performs supplemental investigations/projects as required by Management.

• Maintains knowledge of current GMPs and regulatory guidelines.
  

Requirements:

• 2+ years of experience with GMP, Quality, and compliance.

• Experience with quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.

• Must have experience with deviations, SOP writing, Project Management, Pharma background

• Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.

• Good understanding of electronic document management and manufacturing execution
  systems.

• Has advanced computer skills to increase department's productivity, as well as broadening
  technical and scientific knowledge.

• B.S. Degree required

Please submit your resume to our network at (please apply to the QA Label Control Specialist- Pharma (Onsite- Summit, NJ) role).