This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Analytical QA Associate III (98860) in the United States.
This role offers an exciting opportunity for an experienced analytical professional to ensure the quality and compliance of pharmaceutical products within a cGMP laboratory environment. The position involves reviewing, verifying, and maintaining laboratory documentation, monitoring adherence to Good Laboratory Practices (GLP), and supporting cross-functional teams to ensure regulatory and quality standards are met. You will work on investigations, method validations, and audits while contributing to process improvements. This role requires attention to detail, strong technical knowledge, and the ability to work independently or as part of a team in a fast-paced, dynamic manufacturing and laboratory setting.
Accountabilities
- 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.
Requirements
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field (Master’s preferred).
- 5–8 years of analytical experience, including a 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.
- Experience in inhalation products (MDI) is a plus.
Benefits
- Competitive 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.
Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.
When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.
The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role.
Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps, such as interviews or additional assessments, are then handled by their internal hiring team.
