Quality Assurance Specialist - Hybrid, On-Site 3 Days

Sharp Services; Bethlehem (Northampton County); Hybrid; USD 60,000 - 90,000; Full time

Job summary

Sharp Services is seeking a Quality Assurance Specialist in Bethlehem, PA. The role ensures product and process quality, cGMP compliance, and adherence to Sharp SOPs by reviewing and approving compliance documentation.

You will promote Right First Time across departments and maintain detailed records. Responsibilities include reviewing batch records, QC reports, labels, and analytical reports; preparing APRs; participating in CAPAs and change control; training staff; and maintaining a compliant,

Qualifications

• Bachelor's or Associate degree in science or technical field preferred.
• 3 years relevant work experience in a cGMP environment.
• Excellent communication and organizational skills; ability to work independently and meet deadlines.
• Ability to interpret and implement cGMPs, FDA & DEA regulations.

Responsibilities

• Review and approve batch records to ensure cGMP compliance.
• Review and approve QC reports for components and bulk drug product.
• Review and approve labels for release to production.
• Prepare APR reports in compliance with FDA and EU regulations.
• Investigate non-conformances and participate in CAPA and change control.
• Train employees in cGMPs and SOPs.
• Maintain accurate records; collaborate with cross-functional teams.
• Maintain a safe, clean work environment and participate in meetings.

Skills

cGMP compliance

Quality documentation

Attention to detail

Oral and written communication

MS Office

Independent work

Time management

Process improvement

Education

Bachelor's or Associate degree in science/technical field

Tools

Microsoft Office

Job description

Sharp Services is seeking a Quality Assurance Specialist in Bethlehem, PA. The role ensures product and process quality, cGMP compliance, and adherence to Sharp SOPs by reviewing and approving compliance documentation.

You will promote Right First Time across departments and maintain detailed records. Responsibilities include reviewing batch records, QC reports, labels, and analytical reports; preparing APRs; participating in CAPAs and change control; training staff; and maintaining a compliant,