Quality Assurance Specialist – Hybrid, cGMP & Compliance

Sharp Services, LLC; Bethlehem (Northampton County); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid on-site work arrangement

Job summary

Sharp Clinical Bethlehem is seeking a Quality Assurance Specialist to ensure product and process quality, cGMP compliance and SOP adherence across departments. You will review batch records, QC reports, labels, and COAs, and prepare APRs in line with FDA/EU regs.

You will train staff, participate in CAPA and change control, and maintain accurate records in a collaborative, hybrid on-site role requiring at least three on-site days weekly.

Qualifications

• Bachelors’ Degree, Associates Degree, or equivalent in science or technical related field preferred.
• 3 years relevant work experience in a cGMP environment.
• Excellent oral and written communication and strong attention to detail.

Responsibilities

• Review and approve pre-execution and post-execution batch records for cGMP compliance and SOP adherence.
• Review and approve QC reports, labels, and COAs to ensure quality standards are met.
• Prepare APRs in compliance with FDA and EU regulations.
• Participate in non-conformance investigations, CAPA and change control.
• Train employees in cGMPs and SOPs and maintain detailed records.

Skills

cGMP knowledge

Attention to detail

Oral and written communication

Education

Bachelor's Degree or Associate's Degree in science or technical field

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Microsoft Access

Job description

Sharp Clinical Bethlehem is seeking a Quality Assurance Specialist to ensure product and process quality, cGMP compliance and SOP adherence across departments. You will review batch records, QC reports, labels, and COAs, and prepare APRs in line with FDA/EU regs.

You will train staff, participate in CAPA and change control, and maintain accurate records in a collaborative, hybrid on-site role requiring at least three on-site days weekly.