ECLARO ยท 7 hours ago
QA CTO Label Specialist
Summit, NJ
Contract
Onsite
Entry Level
$35.71/hr - $37.87/hr
2+ years expECLARO is a company that delivers life-changing healthcare solutions, and they are seeking a QA CTO Label Specialist for their client in the Biopharmaceutical Industry. The role involves supporting label control activities, ensuring compliance with policies and regulations, and improving quality processes within the organization.
Staffing & Recruiting
Responsibilities
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
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
Qualification
Required
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
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
B.S. Degree required, minimum 2 years relevant work experience
Benefits
401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
Company
ECLARO
ECLARO is an award-winning professional services firm headquartered in New York City and operating in the U.S., Canada and the Philippines.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Nicholas Butcher
QA CTO Label Specialist
Dan Broderick
Chief Delivery Officer
Company data provided by crunchbase