Quality Assurance Associate — GxP & Audits (Hybrid)

Discovery Life Sciences; Northern (KY); Hybrid; USD 45,000 - 60,000; Full time

Benefits offered by this job

Free dental and vision package

Life insurance

Disability coverage

401(k) match

Generous vacation and PTO

Parental/family leave

Professional development reimbursement

Team-building events

Employee Referral Program

Job summary

Discovery Life Sciences is seeking a Quality Assurance Associate to join our Global Quality & Regulatory team in a hybrid role, primarily based in Newtown, PA. You will apply ALCOA+ data integrity, GDP, and risk-based quality methods to review global scientific, technical, and quality records to ensure regulatory and customer requirements are met.

The ideal candidate has a biology/chemistry background, up to 2 years of QA or regulated experience, and familiarity with audits.

Qualifications

• Bachelor's degree in a scientific field and related experience may be considered.
• 0–2 years in Quality Assurance or regulated environments.
• Internship or lab experience in a regulated setting is a plus.
• Excellent MS Office skills required; familiarity with GDP and ALCOA+ is expected.
• Candidates with PMP/ASQ certifications are encouraged to apply.

Responsibilities

• Review GxP-regulated documents for compliance, accuracy, and quality.
• Support audits by documenting requests and coordinating responses.
• Assist with CAPA tracking and quality investigations.
• Collaborate with global teams including Germany to ensure compliance.
• Develop controlled documents and participate in internal audits.

Skills

Attention to detail

Regulatory/GxP familiarity

Auditing experience

Communication skills

Education

Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or related scientific discipline

PMP certification or ASQ certifications

Tools

MS Word

Excel

PowerPoint

OneNote

Job description

Discovery Life Sciences is seeking a Quality Assurance Associate to join our Global Quality & Regulatory team in a hybrid role, primarily based in Newtown, PA. You will apply ALCOA+ data integrity, GDP, and risk-based quality methods to review global scientific, technical, and quality records to ensure regulatory and customer requirements are met.

The ideal candidate has a biology/chemistry background, up to 2 years of QA or regulated experience, and familiarity with audits.