Address
Form of work Job Description: 100% onsite
Job Title: CTO QA Label Specialist
Number of positions-2
Shift: This position is scheduled for Wed- Sat ( 8 pm - 6am)
Location: US- NJ- Summit West, S12
PURPOSE AND SCOPE OF POSITION:
The Quality Assurance 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 Cell Therapy Development and
Operations (CTDO).
The Quality Assurance 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- 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 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
Education and Experience:
B.S. Degree required, minimum 2 years relevant work experience
Equivalent combination of education and experience acceptable
DUTIES AND RESPONSIBILITIES:
- Supports all activities for the Quality Assurance 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 (US Only):
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.
This job description is intended to describe the general nature and level of work being performed
by the person assigned to this position. The primary duties and responsibilities are intended to
describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities
assigned to this position. There are other duties and responsibilities that are considered
incidental or secondary to the overall purpose of this job. Employees holding this position will be
required to perform any other job-related duties as requested by management.
Job Title: CTO QA Label Specialist
Number of positions-2
Shift: This position is scheduled for Wed- Sat ( 8 pm - 6am)
Location: US- NJ- Summit West, S12
PURPOSE AND SCOPE OF POSITION:
The Quality Assurance 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 Cell Therapy Development and
Operations (CTDO).
The Quality Assurance 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- 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 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
Education and Experience:
B.S. Degree required, minimum 2 years relevant work experience
Equivalent combination of education and experience acceptable
DUTIES AND RESPONSIBILITIES:
- Supports all activities for the Quality Assurance 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 (US Only):
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.
This job description is intended to describe the general nature and level of work being performed
by the person assigned to this position. The primary duties and responsibilities are intended to
describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities
assigned to this position. There are other duties and responsibilities that are considered
incidental or secondary to the overall purpose of this job. Employees holding this position will be
required to perform any other job-related duties as requested by management.
