Pharma QC Inspector: Production & cGMP Compliance

Sharp Clinical Services; Bethlehem (Northampton County); On-site; USD 42,000 - 54,000; Full time

Job summary

Sharp Clinical Services is seeking a Quality Control Inspector I to ensure compliance in cGMP programs, oversee documentation, and support operations and packaging processes. The role requires performing inspections, sampling, and verifying test results while maintaining detailed records and adhering to safety standards.

The ideal candidate has strong communication skills and the ability to work independently, with prior pharma/biotech experience preferred.

Qualifications

• High School Diploma or equivalent in related field preferred.
• 1 year of pharmaceutical or biotech manufacturing/packaging experience preferred.
• Excellent oral and written communication to interact with team and external contacts.
• Ability to interpret and apply cGMPs, FDA & DEA CFRs.

Responsibilities

• Perform quality control inspections on components, in-process items and finished products.
• Determine in-process test standards and ensure compliance with procedures.
• Sample and inspect bulk drug and excipients; maintain reserve samples.
• Verify drug product and components against approved manufacturing instructions.
• Maintain accurate, detailed records of work performed; communicate issues promptly.
• Adhere to safety standards and keep work environment clean and organized.

Skills

Oral and written communication

Independent work ability

cGMP/FDA/DEA regulation interpretation

Attention to detail

Education

High School Diploma or equivalent

Bachelor's degree or equivalent preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Job description

Sharp Clinical Services is seeking a Quality Control Inspector I to ensure compliance in cGMP programs, oversee documentation, and support operations and packaging processes. The role requires performing inspections, sampling, and verifying test results while maintaining detailed records and adhering to safety standards.

The ideal candidate has strong communication skills and the ability to work independently, with prior pharma/biotech experience preferred.