Jobgether is looking for an Analytical QA Associate III to ensure the quality and compliance of pharmaceutical products within a cGMP laboratory environment. You will review, verify, and maintain laboratory documentation, monitor adherence to Good Laboratory Practices (GLP), and support cross-functional teams to meet stringent regulatory and quality standards.
What You'll Do
- Review and confirm compliance of analytical documents for raw materials, in-process, and finished products.
- Monitor laboratory personnel to ensure adherence to cGLP procedures and protocols.
- Evaluate method validation, verification, comparison reports, and other study documentation for compliance.
- Prepare and review laboratory investigation reports, including OOS, OOT, and deviations.
- Verify laboratory reagents, chemicals, and standards according to SOPs.
- Implement Pharmacopoeia changes and ensure alignment with regulatory requirements.
- Participate in laboratory audit reviews and cross-functional coordination to provide necessary documentation.
- Maintain proper tracking, recording, storage, and archival of laboratory documents.
- Identify system gaps during monitoring and suggest improvements to supervisors.
- Support departmental and cross-functional projects and assignments as needed.
What We're Looking For
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
- 5–8 years of analytical experience.
- Minimum of 3 years in analytical quality assurance.
- Proficiency with Microsoft Office and quality management software applications.
- Strong knowledge of laboratory practices including APIs, drug products, analytical development, QC, GLP/GMP/GDP, and USP monograph requirements.
- Understanding of laboratory equipment operations, qualifications, calibrations, and audit trail reviews (e.g., HPLC, GC, UV-Vis, pH meters, stability chambers).
- Familiarity with FDA and ICH guidance requirements.
- Strong technical writing and documentation skills.
- Excellent interpersonal, communication, and teamwork abilities.
- Ability to work in a fast-paced, dynamic manufacturing environment with minimal supervision.
Nice to Have
- Master’s degree.
- Experience in inhalation products (MDI).
Benefits & Compensation
- Salary range: $72,800 – $93,600
- Comprehensive health, dental, and vision coverage.
- Paid time off and holidays.
- Opportunities for professional development and training.
- Collaborative work environment with cross-functional exposure.
- Experience in a cGMP-compliant laboratory setting.
Work Mode
This is a remote position open to candidates located within the United States.
Jobgether is an equal opportunity employer.
