Quality Assurance Associate

ProQuality Network; Kentucky; Hybrid; USD 52,000 - 70,000; Full time

Job summary

ProQuality Network is seeking a Quality Assurance Associate to support our biotechnology client in a GMP environment. This contract-to-hire role focuses on reviewing analytical documentation and ensuring regulatory compliance in a fast-paced operations setting.

The ideal candidate will have a Bachelor's degree in a scientific discipline and at least 3 years of GMP experience, with strong attention to detail and cross-functional communication.

Qualifications

• Bachelor’s degree in a scientific discipline (Chemistry/Biochemistry preferred).
• Minimum of 3 years of GMP industry experience.
• Experience in analytical labs, QC/QA within regulated environments.

Responsibilities

• Review analytical release and stability data to ensure GMP compliance.
• Review and approve controlled documents, including protocols, test methods, and specifications.
• Evaluate analytical documentation with minimal supervision.
• Ensure documentation accuracy, completeness, and regulatory compliance.
• Collaborate with cross-functional teams to support quality objectives and regulatory compliance.

Skills

Critical thinking

Attention to detail

Organizational skills

GMP regulations

Education

BSc Chemistry

BSc Biochemistry

Job description

Job Title: Quality Assurance Associate (Biotechnology Industry) – 15014638 / 3556776

Location: Kentucky, U.S. (Open to local residents)

Positions Available: 1

Work Arrangement: Onsite

Shift: Monday – Friday | 2:00 PM – 10:30 PM

Position Summary:

ProQuality Network is seeking a Quality Assurance Associate to support our client in the biotechnology industry. This is a contract-to-hire opportunity designed to assist with quality operations in a regulated GMP environment. The selected candidate will be responsible for reviewing analytical documentation and ensuring compliance with established regulatory requirements and internal quality systems.

The ideal candidate will demonstrate strong critical thinking, attention to detail, and organizational skills, along with the ability to make sound decisions based on applicable GMP regulations. Professional, effective, and proactive communication with peers, management, and cross-functional teams is essential to support quality and compliance across operations.

Key Responsibilities:

• Review analytical release and stability data to ensure compliance with GMP and internal quality standards.
• Perform review and approval of controlled documents, including protocols, test methods, and specifications.
• Evaluate analytical documentation such as test methods, protocols, and stability/release data with minimal supervision.
• Ensure documentation accuracy, completeness, and compliance with regulatory and quality system requirements.
• Collaborate with cross-functional teams to support quality objectives and maintain regulatory compliance.

Education and Experience:

• Bachelor’s degree in a scientific discipline, preferably Chemistry or Biochemistry.
• Minimum of 3 years of GMP industry experience.
• Relevant experience in analytical laboratories, Quality Control (QC), manufacturing, or Quality Assurance (QA) within regulated environments.