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Our client, a leading pharmaceutical company, is hiring a
CTO QA Label Specialist,
on a contract basis.
Job ID: 82680
Work Location:
Summit, NJ - 100% on site
Summary:
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 company 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.
Education/Experience:
B.S. Degree required, 2 years relevant work experience
Knowledge/Skills:
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. Requires 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 departments 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
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.
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.
Pay: $33-$35/hr
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Information Technology Industries
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Our client, a leading pharmaceutical company, is hiring a
CTO QA Label Specialist,
on a contract basis.
Job ID: 82680
Work Location:
Summit, NJ - 100% on site
Summary:
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 company 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.
Education/Experience:
B.S. Degree required, 2 years relevant work experience
Knowledge/Skills:
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. Requires 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 departments 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
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.
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.
Pay: $33-$35/hr
The post appeared first on .
Seniority level
Seniority level
Entry level Employment type
Employment type
Full-time Job function
Job function
Information Technology Industries
Software Development Referrals increase your chances of interviewing at Jobs via Dice by 2x Get notified about new Chief Technology Officer jobs in
Summit, NJ . New York, NY $450,000 - $500,000 2 weeks ago Senior Vice President, Chief Technology and Digital Officer
New York, NY $350,000 - $375,000 2 weeks ago New York City Metropolitan Area $270,000 - $350,000 1 week ago New York, NY $250,000 - $300,000 1 week ago Business Execution Lead - CIO/Functions & Enterprise Change, MD
New York, NY $250,000 - $500,000 1 week ago Vice President, Streaming Strategy & Ad Tech - VERSANT
New York, NY $220,000 - $275,000 2 days ago New York, NY $68,000 - $113,000 6 hours ago CTO / Head of Engineering - Dragonfly Portfolio
Jersey City, NJ $147,000 - $220,000 2 weeks ago Vice President - Corporate Applications & Database Technology
Vice President, Tech Lead - API Center of Enablement
Senior Vice President Communications, Technology, Innovation and Emerging Technologies
New York, NY $105,000 - $175,000 1 week ago Vice President, Technology & Operations M&A Enablement
New York, NY $68,000 - $113,000 5 days ago Vice President of Behavioral Integration - AHRC New York City
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr