Quality Assurance - Label Control Specialist Pharma (Onsite Summit, NJ)
We are seeking a Quality Assurance - Label Control Specialist for a global pharmaceutical company. You will be supporting 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.
This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite role in Summit, NJ. Wednesday - Saturday, 6:30am 4:30pm
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities:
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.
Maintains knowledge of current GMPs and regulatory guidelines.
Occasional lifting of heavy weights up to 25 to 35 lbs.
Requirements:
Must Have Experience: Labeling, deviations, CAPA, SOP writing, Pharma background
Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
Required Bachelor's degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment
Please submit your resume to our network at (please apply to the Quality Assurance - Label Control 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. - $34.96/hr.
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