QA Associate - Audit, Compliance & Process Improvement

Altasciences; Olyphant (Lackawanna County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid vacation & holidays

Sick leave

Telehealth program

Telework when applicable

Job summary

Altasciences is seeking a Quality Assurance Associate to safeguard the integrity of clinical and laboratory research contributing to new medicines. You will work across regulated environments, partnering with scientific, clinical, and operational teams to uphold high quality standards.

As part of a supportive QA team, you will gain exposure to audits, regulatory requirements, quality systems, and process improvements, while growing into roles in QA, Regulatory Affairs, or Clinical Operations.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.
• Basic understanding of pharmaceutical, clinical research, or laboratory environments.
• Familiarity with GCP, GLP, GCLP, ICH guidelines, or other regulated quality systems is preferred.

Responsibilities

• Conducting audits of clinical and laboratory study activities to verify compliance with protocols, SOPs, GxP requirements, and regulatory guidelines.
• Reviewing study documentation, reports, and data to ensure accuracy, consistency, and completeness.
• Partnering with teams across Clinical Operations, Laboratory Services, Data Management, Recruiting, Screening, Bioanalytical Sciences, and other functional areas to support quality initiatives.
• Preparing clear, concise, and actionable audit and inspection reports.
• Communicating audit observations and findings effectively to stakeholders and supporting the development of corrective actions.
• Verifying that SOPs are current, followed consistently, and aligned with regulatory expectations.
• Participating in a variety of quality activities, including: Study audits In-life audits Process audits Vendor qualifications Equipment validation reviews Software validation assessments
• Identifying trends, risks, and opportunities for process improvements that strengthen quality systems and operational effectiveness.
• Maintaining organized and accurate quality records and audit documentation.
• Interpreting and applying GCP, GLP, and GCLP regulations to support compliant study conduct.
• Collaborating with experienced QA mentors to expand knowledge and technical expertise.
• Contributing to a culture of continuous improvement, compliance, and operational excellence.

Skills

Auditing

GxP knowledge

Regulatory compliance

Documentation review

Cross-functional teamwork

Education

Bachelor's degree in life sciences

Tools

MasterControl

Watson LIMS

Analyst software

Job description

Altasciences is seeking a Quality Assurance Associate to safeguard the integrity of clinical and laboratory research contributing to new medicines. You will work across regulated environments, partnering with scientific, clinical, and operational teams to uphold high quality standards.

As part of a supportive QA team, you will gain exposure to audits, regulatory requirements, quality systems, and process improvements, while growing into roles in QA, Regulatory Affairs, or Clinical Operations.