Quality Assurance Associate

121 Altasciences Preclinical Scranton, Inc; Scranton (Lackawanna County); On-site; USD 55,000 - 90,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Telework when applicable

Job summary

Altasciences is seeking a Quality Assurance Associate to safeguard clinical and laboratory research, ensuring studies meet GxP and regulatory standards. You will work across Clinical Operations, Laboratory Services, Data Management, Recruiting, and more to support quality initiatives and drive continuous improvement.

You will review study documentation, participate in audits, and help develop corrective actions while collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in a scientific discipline (Biology, Chemistry, etc.)
• Familiarity with regulated quality systems (GCP/GLP/GCLP) preferred
• Strong documentation and audit-reporting abilities

Responsibilities

• Conduct audits of clinical and laboratory activities for protocol and SOP compliance.
• Review study documentation and data for accuracy and completeness.
• Collaborate with Clinical Operations, Laboratory Services, Data Management, and other teams to support quality initiatives.
• Prepare clear audit and inspection reports and lead corrective action development.

Skills

Quality assurance

Regulatory awareness

Auditing

Documentation

Communication

Education

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

Tools

MasterControl

Watson LIMS

Analyst software

Job description

About the Role

Are you passionate about quality, compliance, and ensuring scientific excellence? As a Quality Assurance Associate, you will play a vital role in safeguarding the integrity of clinical and laboratory research that contributes to the development of new medicines and therapies. This position offers an exciting opportunity to work across multiple areas of a regulated research environment, partnering with scientific, clinical, and operational teams to ensure studies are conducted to the highest quality standards. You'll gain valuable exposure to audits, regulatory requirements, quality systems, and process improvement initiatives while building expertise that can serve as a foundation for a long-term career in Quality Assurance, Regulatory Affairs, Clinical Research, or Compliance. Working alongside experienced QA professionals and mentors, you'll help drive a culture of quality and continuous improvement throughout the organization.

What You'll Do

• Conducting audits of clinical and laboratory study activities to verify compliance with protocols, Standard Operating Procedures (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 appropriate 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 your knowledge and technical expertise.
• Contributing to a culture of continuous improvement, compliance, and operational excellence.

What You'll Need to Succeed

• 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.

Skills & Attributes

• Passionate about quality, compliance, and scientific integrity.
• Naturally curious and analytical with strong problem-solving abilities.
• Highly organized and capable of managing multiple priorities simultaneously.
• Detail-oriented with a commitment to accuracy and thoroughness.
• Comfortable reviewing technical documents and identifying inconsistencies.
• Skilled communicators who can confidently interact with cross-functional teams.
• Adaptable and able to thrive in a fast-paced, evolving environment.
• Dependable professionals who demonstrate sound judgment, discretion, and integrity.

Technical Skills

• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Experience with quality management systems, electronic document systems, or laboratory software is an asset.
• Familiarity with MasterControl, Watson LIMS, or Analyst software is considered a plus.

Why Join Us?

Gain hands‑on experience in Quality Assurance within a regulated pharmaceutical and clinical research environment. Collaborate with scientists, clinicians, laboratory professionals, and quality experts. Develop expertise in auditing, regulatory compliance, quality systems, and process improvement. Receive mentorship and professional development opportunities from experienced QA leaders. Build a strong foundation for future career growth in Quality Assurance, Regulatory Affairs, Validation, Clinical Operations, Compliance, or Project Management. Make a meaningful impact by helping ensure the quality and integrity of research that supports the development of innovative therapies.

Benefits

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable.

Incentive Programs

• Training & Development Programs
• Employee Referral Bonus Program

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well‑being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences.

Equal Opportunity Employer

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.

Work Authorization & Sponsorship

Applicants must be legally authorized to work in the United States. Altasciences is unable to provide sponsorship, sponsorship transfers, or visa maintenance for this position. All applicants must possess valid work authorization that does not require employer sponsorship now or in the future.