QA Specialist II: GMP Quality Assurance & Compliance

Quality Talent Group; Penryn (PA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement program

EAP and mental well-being resources

Well-being reimbursement

Job summary

Quality Talent Group is seeking a Quality Assurance professional in Pennsylvania to support GMP documentation reviews, ensure product conformance, and drive compliance across production lines.

You will review production records, release finished products, and collaborate with Operations to resolve quality issues and implement improvements. A Bachelor’s degree and at least 2 years of GMP experience are required, with strong communication skills essential.

Qualifications

• A Bachelor’s degree is required.
• At least 2 years of GMP experience in pharmaceutical, medical device, OTC, cosmetics or dietary supplements production.
• Working knowledge of cGMP requirements and current FDA enforcement issues.
• Strong verbal and written communication skills.
• Demonstrated ability to meet work goals.

Responsibilities

• Perform quality review of production records including manufacturing, packaging, and laboratory documents.
• Responsible for releases of finished product based on conformance to established standards.
• Apply quality assurance processes, procedures, and activities.
• Conduct walkthroughs and assessments of GMP areas.
• Partner with Operations to address quality/compliance issues and improvements.

Skills

GMP experience

Quality assurance

Document control

Communication

Education

Bachelor's degree

Job description

Quality Talent Group is seeking a Quality Assurance professional in Pennsylvania to support GMP documentation reviews, ensure product conformance, and drive compliance across production lines.

You will review production records, release finished products, and collaborate with Operations to resolve quality issues and implement improvements. A Bachelor’s degree and at least 2 years of GMP experience are required, with strong communication skills essential.