QA Label Control Specialist - Cell Therapy (GMP Manufacturing)

The Label Control Specialist at the Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at the facility 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 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

DUTIES AND RESPONSIBILITIES:

• Supports all activities for the Label Control group.
• Responsible for issuing clinical and commercial in-process and final product labels for labelingoperations.
• Responsible for ensuring accurate printed information on labels in compliance with healthauthority 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 stepsnecessary 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 otherquality 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, productcomplaints, deviations, investigations and CAPA management.
• Performs supplemental investigations/projects as required by Management.
• Maintains knowledge of current GMPs and regulatory guidelines.

Requirements

EDUCATION:

• B.S. degree 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 otherteam members in technical writing skills.
• Requires moderate direction to complete more complex tasks; completes routing tasks withlittle or no supervision.
• Must be time organized and possess an independent mindset.
• Good understanding of electronic document management and manufacturing executionsystems.
• Has advanced computer skills to increase department’s productivity, as well as broadeningtechnical and scientific knowledge.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and addresses quality opportunities to improve overall process/projectefficiencies.
• Proposes solutions for complex issues and works with management to resolve. Followsestablished procedures and performs work as assigned.
• Builds relationships and effectively communicates internally within the function and withinternal 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 forresolution.
• Able to prepare written communications and communicate problems to management withclarity and accuracy.
• Able to produce data reports with precision.
• Able to multi-task.Able to support internal and health authority inspections of facility

WORKING CONDITIONS:

• Work is performed in a typical office environment, with standard office equipment available and used.
• Work is generally performed seated but may require standing and walking for up to 10% of the time.
• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

Benefits

Competitive hourly rate: $28 – $35/hr (W-2 only, no C2C)

Working Hours: Wednesday- Saturday, 6.30am- 4.30pm

6-month contract with possible extension

Health insurance, holiday pay, 401(k) program, and other benefits

Employee referral bonus program