Pharmaceutical QC Coordinator; Protocol Writing

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

For immediate consideration please send your resume to

Subject Line:
Position Title and State you are located

About Us:

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:

Pharmaceutical 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-$35.75/HR

This is an exciting opportunity for a QA professional to join a Life Sciences Quality and Regulatory team at a manufacturing site in Wilmington, DE. This highly visible role reports directly to the on-site Quality Manager. The primary responsibility of this role is to manage, maintain, and continuously improve the site Quality Management System (QMS) while ensuring compliance with FDA regulations, cGMP requirements, ISO standards, and internal quality objectives.

A critical component of this role is hands‑on authorship of protocols and procedures, drafting and finalizing reports, and managing change control processes.

• Write validation and testing protocols in accordance with FDA regulations and cGMP requirements (protocol writing is a core responsibility)
• Draft SOPs and procedures from scratch
• Complete assessment reports following protocol execution
• Draft, review, and finalize technical reports after testing activities
• Support laboratory testing once protocols have been written
• Manage and execute Change Controls (MOCs)
• Establish, maintain, and continuously improve the site Quality Management System (QMS)
• Maintain and improve site quality procedures and documentation systems
• Ensure strong document management and data integrity practices
• Support ISO 9001 and cGMP activities
• Investigate customer complaints, deviations, and OOS events
• Support stability programs and site validation projects
• Perform raw material and finished product retesting
  
  Review batch records and perform final product release in iLIMS and SAP
• Set up new products in iLIMS
• Conduct product compliance reviews against applicable compendial requirements
• Support qualification of new laboratory equipment
• Provide regulatory documentation support, including Drug Master File (DMF) documentation
• Respond to quality and regulatory customer inquiries
• Conduct risk assessments to identify hazards and implement appropriate controls
• Adhere to ethical standards in research and data reporting

• Bachelor’s degree in Chemistry, Biology, or related scientific discipline (or equivalent experience)
• 5–8 years of Quality Assurance experience in a regulated pharmaceutical or life sciences environment
• Strong knowledge of FDA regulations, laboratory cGMP, GLP, and safety requirements
• Demonstrated hands‑on experience writing protocols and drafting procedures from the ground up (first requirement)
• Experience drafting and completing technical reports following assessments or testing
• Experience supporting testing activities after protocol development
• Strong working knowledge of Change Control processes
• Experience working within and improving Quality Management Systems
• Experience with SAP and iLIMS
• Proficiency in Microsoft Office Suite
• Strong written and verbal communication skills
• Ability to read, interpret, analyze, and report technical data
• Proven ability to work effectively in a cross‑functional team environment

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.

JD# 25-00040