Overview
On Site
USD 34.97 - 43.97 per hour
Contract - W2
Skills
Quality Assurance
Training
Standard Operating Procedure
Quality Management
Auditing
Change Control
Corrective And Preventive Action
GMP
Regulatory Compliance
Technical Writing
Routing
Supervision
Organized
Document Management
Manufacturing
Productivity
Management
Clarity
Multitasking
Life Insurance
Screening
Writing
Career Counseling
Recruiting
Law
Testing
Job Details
CTO QA Label Specialist - Contract - Summit West, NJ - $34.97 - $ 43.97/hr.
The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.
Applicants must be legally authorized to work in the United States. Sponsorship not available.
Our client is seeking a CTO QA Label Specialist in Summit West, NJ.
Role Description
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.
Skills & Requirements
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.
Benefits/Other Compensation
This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
Nervous about an upcoming interview? Unsure how to write a new resume?
Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.
Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text .
Drug testing may be required; please contact a recruiter for more information.
#LI-DNI
The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.
Applicants must be legally authorized to work in the United States. Sponsorship not available.
Our client is seeking a CTO QA Label Specialist in Summit West, NJ.
Role Description
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.
Skills & Requirements
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.
Benefits/Other Compensation
This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
Nervous about an upcoming interview? Unsure how to write a new resume?
Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.
Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text .
Drug testing may be required; please contact a recruiter for more information.
#LI-DNI
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.