Quality Assurance Associate

Altasciences

Olyphant (Lackawanna County)

On-site

USD 65,000 - 90,000

Full time

41 hours ago

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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

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.

Required 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.

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.

If you're a detail-oriented science professional who enjoys problem-solving, process improvement, and ensuring work is done right the first time, we invite you to join our Quality Assurance team and help drive excellence across every stage of the research process.

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.

What We Offer

Benefits

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences Benefits Package Includes