QA Specialist II — GMP & Quality Assurance Expert

Quality Talent Group; Clay (PA); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement plan

Employee Assistance Program (EAP)

Well-being resources

Global parental leave

Adoption benefits

Volunteer time

Job summary

Quality Talent Group is seeking a Quality Assurance professional with GMP experience to ensure product conformity and regulatory compliance across production records. The role involves reviewing production documents, releasing finished products, and applying QA processes in a fast-paced environment.

Candidates should hold a Bachelor’s degree and have at least two years of GMP experience in pharma, medical devices, cosmetics, or dietary supplements, with strong communication skills and a proven

Qualifications

• Bachelor's degree required.
• Minimum 2 years of GMP experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production.
• Basic working knowledge of cGMP requirements and current FDA enforcement issues.
• Ability to communicate thoughts and ideas effectively – verbal and written.
• Demonstrated ability to accomplish 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

cGMP knowledge

Communication skills

Goal accomplishment

Education

Bachelor's degree

Job description

Quality Talent Group is seeking a Quality Assurance professional with GMP experience to ensure product conformity and regulatory compliance across production records. The role involves reviewing production documents, releasing finished products, and applying QA processes in a fast-paced environment.

Candidates should hold a Bachelor’s degree and have at least two years of GMP experience in pharma, medical devices, cosmetics, or dietary supplements, with strong communication skills and a proven