Label Control Specialist

ECLARO; Summit (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

ECLARO is seeking a QA CTO Label Specialist for a 6-month contract in Summit, NJ. The role involves supporting label control activities in a biopharmaceutical setting, ensuring compliance with GMP and health authority requirements. Successful candidates will possess strong technical writing skills and a solid understanding of quality processes. This position offers competitive pay and health benefits and is critical to ensuring patient safety in drug manufacturing.

Benefits

401k Retirement Savings Plan

Medical, Dental & Vision Insurance

Qualifications

• Minimum 2 years relevant work experience required.
• Familiarity with quality processes including label control.
• Confident in making decisions for non-routine issues.

Responsibilities

• Supports all activities for the Label Control Group.
• Responsible for issuing clinical and commercial labels.
• Ensures compliance with health authority requirements.

Skills

GMP Knowledge

Technical Writing

Time Management

Problem Solving

Education

B.S. Degree

Tools

Electronic Document Management

Manufacturing Execution Systems

Job description

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This range is provided by ECLARO. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$35.00/hr - $37.00/hr

Direct message the job poster from ECLARO

Duration: 6 months initial (potential extension/potential right to hire)

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

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a QA CTO Label Specialist for our client in Summit, NJ.

ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

• The Label Control Specialist at the S-12 Cell Therapy Manufacturing Facility is responsible for supporting 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 Client.
• 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.

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.
• 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.

Required Qualifications:

• 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.
• Moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.
• Must be time organized and possess an independent mindset.
• 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.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and addresses quality opportunities to improve overall process / project efficiencies.
• Proposes solutions for complex issues and works with management to resolve.
• Follows established procedures and performs work as assigned.
• Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams.
• Interacts with internal and external cross functional teams.
• Represents department in internal and external cross-functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to produce data reports with precision.
• Able to multi-task.
• Able to support internal and health authority inspections of facility.
• B.S. Degree, minimum 2 years relevant work experience.

Pay Rate: $35 - $37 / Hour

If hired, you will enjoy the following ECLARO Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

If hired, you will enjoy the following Eclaro Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to [e-mail] or call [phone].

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance and Other

• Industries

  Pharmaceutical Manufacturing

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