Quality Assurance Specialist II: GMP & Release Expert

Quality Talent Group; Clay (PA); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Competitive benefits

Paid time off

Health insurance

Retirement plan

EAP & wellbeing resources

Global parental leave

Learning & development

Job summary

Quality Talent Group seeks a detail-oriented Quality Assurance professional to oversee GMP-compliant production records and ensure conformance to standards across manufacturing, packaging, and laboratory documentation. The role requires collaboration with Operations to address quality and compliance improvements.

Ideal candidates have a Bachelor's degree and 2+ years of GMP experience in consumer health sectors, with strong written and verbal communication skills and knowledge of cGMP and FDA

Qualifications

• Minimum of a Bachelor's Degree.
• At least 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 compliance

Quality assurance

Documentation review

Communication skills

Education

Bachelor's degree

Job description

Quality Talent Group seeks a detail-oriented Quality Assurance professional to oversee GMP-compliant production records and ensure conformance to standards across manufacturing, packaging, and laboratory documentation. The role requires collaboration with Operations to address quality and compliance improvements.

Ideal candidates have a Bachelor's degree and 2+ years of GMP experience in consumer health sectors, with strong written and verbal communication skills and knowledge of cGMP and FDA