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Job Title :QA Label Specialist
Location : Summit, NJ
Hours/Schedule : Wednesday - Saturday; 2nd Shift (4p - 2am)
Type: Contract
Overview
The Quality Assurance Label Control (QALC) Labeling Specialist supports the cGMP Label Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records.
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.
P erforms 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.
Requirements
Bachelors degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment
Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
Some document management experience.
Crystal reports experience preferred .
Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
Possess project management skills.
Experience interacting with FDA or other regulatory agencies strongly preferred.
Strong knowledge of cGMPs and domestic regulatory requirements.
Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #568-Clinical
Seniority level
Seniority level Entry level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Staffing and Recruiting Referrals increase your chances of interviewing at Joulé by 2x Sign in to set job alerts for “Quality Assurance Specialist” roles.
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#J-18808-Ljbffr
Location : Summit, NJ
Hours/Schedule : Wednesday - Saturday; 2nd Shift (4p - 2am)
Type: Contract
Overview
The Quality Assurance Label Control (QALC) Labeling Specialist supports the cGMP Label Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records.
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.
P erforms 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.
Requirements
Bachelors degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment
Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
Some document management experience.
Crystal reports experience preferred .
Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
Possess project management skills.
Experience interacting with FDA or other regulatory agencies strongly preferred.
Strong knowledge of cGMPs and domestic regulatory requirements.
Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #568-Clinical
Seniority level
Seniority level Entry level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Staffing and Recruiting Referrals increase your chances of interviewing at Joulé by 2x Sign in to set job alerts for “Quality Assurance Specialist” roles.
Quality Assurance Manager-Data Integrity/GMP/CSV
Manhattan, NY $58,700.00-$63,301.00 1 year ago New York City Metropolitan Area $140,000.00-$190,000.00 3 hours ago New York, NY $90,000.00-$110,000.00 1 week ago Morris Plains, NJ $85,400.00-$158,600.00 1 week ago Quality Assurance Specialist, Office of Mental Health (OMH) Supported Housing Program
Millburn, NJ $81,200.00-$150,800.00 11 hours ago Piscataway, NJ $40,000.00-$300,000.00 3 months ago East Brunswick, NJ $55,000.00-$65,000.00 2 weeks ago Millburn, NJ $81,200.00-$150,800.00 5 days ago Senior Quality Assurance Specialist - 709130
Manhattan, NY $40,957.00-$59,190.00 2 months ago Supervisory Quality Assurance Specialist
QA Tester with Capital Markets Experience - NYC (Hybrid)
Fine Jewelry Quality Assurance Associate
New York, NY $50,000.00-$70,000.00 1 week ago New York, NY $90,000.00-$110,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr