Job Description

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

We are seeking a QA Label Specialist - Pharma for a global pharmaceutical client. You will support site Label Control activities at S-12 in accordance with client 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).

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

This position is scheduled 2nd shift for Sun-Wed (4 pm-2:00 am)

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 an0d 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.

Requirements:

• Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment

• 1+ years of experience in the Biopharma

• 1+ years of quality experience

• 3+ years with MS Office 365

• Some document management experience.

• Must have knowledge and experience with GMP, Quality, and compliance.

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

• Crystal Reports and BarTender experience preferred.

• Bachelor's Degree in Science is required.
  
  

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

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $30/hr. - $34.97/hr.

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