QA Advisor III (GLP a must and highlighted on resume)

Resolian Inc.

Malvern (Chester County)

On-site

USD 95,000 - 130,000

Full time

2 days ago
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Job summary

Resolian is a global CRO located in Malvern, PA, seeking a QA Advisor III to ensure GLP and GCP data integrity and drive continuous quality improvement. The role involves reviewing SOPs, supporting CAPA activities, and serving as a quality partner across multiple departments.

The candidate should have a BA/BS or higher and 6+ years of experience in a GxP environment, with familiarity with regulatory requirements and good communication skills to mentor teams and lead initiatives in a fast-paced

Qualifications

  • BA/BS or higher; all experiences will be evaluated.
  • Strong communication skills emphasized in the description.
  • Ability to lead projects and meetings, mentor team members, and multitask in a fast-paced environment.

Responsibilities

  • Review SOPs and quality system documents.
  • Evaluate compliance with GLP, GCP, and other regulatory requirements.
  • Support quality events and CAPA activities.
  • Participate in vendor qualification processes.
  • Host client audits.
  • Serve as a quality partner across departments.

Skills

Strong communication
Project leadership
Mentor teammates
Multitask in fast-paced environment

Education

BA/BS or higher

Job description

Resolian – Your global bioanalytical, biomarker and analytical sciences partner supporting all phases of your drug development.

Resolian is a leading global Contract Research Organization (CRO) providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic (DMPK), and GMP CMC analytical and materials science. Its team of more than 400 experts across the US, UK, and Australia, Resolian supports pharma and biotech companies’ programs throughout the entire drug development continuum.

We continually strive to maintain the highest standards of professional ethics, scientific excellence, and regulatory compliance. We work to build trusted partnerships with each of our employees.

Resolian is located in Malvern PA and this is an onsite position M-F.

As a QA Advisor III, you will play a key role in ensuring the quality and integrity of data supporting GLP and GCP studies, while also helping drive continuous improvement across the organization. This is more than a traditional auditing role. It is an opportunity to influence quality culture, strengthen processes, and serve as a trusted quality partner across multiple departments.

Beyond auditing, you will serve as a trusted quality partner to operational and scientific teams by reviewing SOPs and quality system documents, evaluating compliance with applicable regulations, supporting quality events and CAPA activities, participating in vendor qualification processes, and hosting client audits. The position provides broad exposure to both study-related and systems-based quality activities, allowing you to make meaningful contributions that directly impact the success of our organization and our clients.

We are seeking an experienced quality professional who can work independently, manage multiple priorities, lead projects and meetings, mentor team members, and serve as a departmental subject matter expert. Success in this role requires sound judgment, strong communication skills, and a proactive approach to identifying opportunities for improvement and implementing practical solutions.

Education, Experience & Skills Required:
  • BA/BS or higher; all experiences will be evaluated
  • 6+ years experience in GxP Environment, all experiences will be evaluated
  • Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP
  • Familiar with pharmaceutical or biotechnology industry
  • Able to review detailed data and documents
  • Able to work effectively and contribute within a team
  • Able to work with computer systems
  • Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment
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