GMP Quality Control Lead, Production

Sharp Clinical Services; Bethlehem (Northampton County); On-site; USD 85,000 - 110,000; Full time

Job summary

Sharp Clinical Services seeks a Quality Control Lead, Production to ensure adherence to cGMP, GDP and company procedures on the production floor, overseeing inspections, testing and documentation.

The role requires strong attention to detail, the ability to author SOPs, train QC staff, manage change controls and CAPAs, and collaborate with production, QA and validation teams to maintain compliant manufacturing and packaging operations.

Qualifications

• High School Diploma or higher; degree preferred in a related field.
• 5 years of pharmaceutical or biotech manufacturing/packaging experience preferred.
• Strong documentation and cGMP understanding required.

Responsibilities

• Perform quality control inspections per established procedures and specifications.
• Determine in-process test standards and ensure compliance with standards.
• Provide guidance on GDP, inspection techniques, and technical questions on shift.
• Author and revise SOPs; train QC trainees on cGMP and procedures.
• Maintain accurate records and report quality or cGMP issues to supervisor.
• Assist in change controls, CAPAs, investigations and non-conformances.
• Ensure testing adheres to current procedures and sampling plans.

Skills

Quality control

cGMP knowledge

Documentation practices

SOP writing

Excel

Education

High School Diploma

Bachelor’s Degree or equivalent

Tools

Inspection instrumentation

Microsoft Office (Word, Project, Excel)

Job description

Sharp Clinical Services seeks a Quality Control Lead, Production to ensure adherence to cGMP, GDP and company procedures on the production floor, overseeing inspections, testing and documentation.

The role requires strong attention to detail, the ability to author SOPs, train QC staff, manage change controls and CAPAs, and collaborate with production, QA and validation teams to maintain compliant manufacturing and packaging operations.