QC Coordinator; Protocol Writing

On-Board Services is hiring a QC Coordinator in Wilmington, DE

For immediate consideration please send your resume to . Subject Line:
Position Title and State you are located.

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Title: QC Coordinator
Position Type: 6 month contract assignment with additional opportunity contingent upon performance and continued business need
Job Location: Wilmington, DE
Shift: 1st Shift
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation: $28.57/HR

This is an exciting opportunity for a QA Specialist to join a Life Sciences Quality and Regulatory team at a manufacturing site in Wilmington, DE. This is a highly visible and impactful role within the organization and the Quality and Regulatory function. The position reports to the on-site Quality Manager.

The primary responsibility of this role is to manage, maintain, and continuously improve the site Quality Management System while ensuring alignment with applicable ISO standards, EXCiPACT and FSSC 22000 requirements, compendial standards, internal objectives, and customer needs.

• Maintain and improve site quality procedures
• Ensure strong document management practices
• Support ISO 9001 and cGMP activities, including:
  • Customer complaint management
  • Stability program support
  • Site cGMP validation projects
  • Customer request support
  • Document maintenance and data analysis
• Perform raw material and finished product retesting
• Establish and maintain the Quality Management System
• Investigate customer complaints and deviations
• Review SOPs and work instructions
• Manage change controls (MOCs)
• Support the product stability program
• Respond to quality and regulatory customer inquiries
• Ensure data integrity
• Set up new products in iLIMS
• Support QC laboratory activities and inspect output samples for quality consistency
• Review batch records and perform final product release in iLIMS and SAP
• Conduct OOS investigations
• Perform product compliance reviews against applicable compendia
• Support qualification of new laboratory equipment
• Provide regulatory documentation support for Drug Master Files (DMFs)
• Support regulatory intelligence activities

• Adhere to ethical standards in research and data reporting
• Conduct risk assessments to identify hazards and implement appropriate controls

• Bachelor’s degree in Chemistry, Biology, or equivalent experience
• 5–8 years of Quality Assurance experience in a regulated industry
• Knowledge of laboratory cGMP, GLP, and safety requirements
• Experience with SAP and iLIMS
• Proficiency in Microsoft Office Suite
• Strong written and verbal communication skills
• Ability to read, interpret, analyze, and report data
• Proven ability to work effectively in a team environment

Apply Today!

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.