QA Label Control Specialist- Pharma (2nd shift) (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 organization supports the S-12 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

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

This position is scheduled for 2nd Shift, Wed-Sat- 4:00pm-2:00am.

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

• Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment preferred
• 1 years of experience in the Biopharma
• 1 years of quality experience, GMP, and compliance.
• 1 years of labeling Experience
• 3 years with MS Office 365
• Some document management experience
• Deviation/CAPA/RCA background is plus.
• Crystal reports and BarTender experience preferred.
• Good understanding of electronic document management and manufacturing execution systems.
• B.S. Degree required
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the QA Label Control Specialist- Pharma (2nd Shift) (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.