Job Posting for QA CTO Label Specialist at Artech LLC
Job Description: 100% onsite
1st Shift: This position is scheduled for Sun-Wed (5:45 am -3:45 pm).
Job Title: CTO QA Label Specialist
Job Description:
The Specialist Quality Assurance Label Control supports the cGMP Label Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records. To succeed in this role, you will have a strong attention to detail and an analytical mindset.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
Education:
Bachelor’s degree or Associate's Degree with 3 Years of Experience in a cGMP/FDA Regulated Environment
Experience Basic Qualifications:
• Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
• Some document management experience.
• Crystal reports and BarTender experience preferred.
• Strong communication and customer service skills.
• 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).
• Develop and improve label issuance processes to drive operational efficiency.
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
• Possess project management skills.
• Experience interacting with FDA or other regulatory agencies strongly preferred.
• Strong knowledge of cGMPs and domestic regulatory requirements.
• Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network.
DUTIES AND RESPONSIBILITIES:
Primary responsibilities include:
• 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):
• Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.
- Weekend and off-shift support may be required.
- Occasional lifting of heavy weights up to 25 to 35 lbs.
Salary.com Estimation for QA CTO Label Specialist in Summit, NJ
$63,451 to $80,154
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
Sign up to receive alerts about other jobs with skills like those required for the QA CTO Label Specialist.
Click the checkbox next to the jobs that you are interested in.