Job Description

Quality Assurance Label Control (QALC) Labeling Specialist - Pharma (Onsite-Summit, NJ)

We are seeking a Quality Assurance Label Control (QALC) Labeling Specialist 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 1st shift scheduled for Sun-Wed (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 Quality Assurance Label Control group.

• Responsible for issuing clinical an0d commercial in-process and final product labels for labeling operations.

• 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 organization supports the S-12 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

• 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:

• 1+ years of experience in the Biopharma
  1+ years of quality experience

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

• 3+ years with MS Office 365

• Some document management experience.

• Crystal reports and BarTender experience preferred

• Bachelors Degree in Science is required.
  
  

Please submit your resume to our network at (please apply to the Quality Assurance Label Control (QALC) Labeling 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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