QA Reviewer: Associate Scientist II (Chemistry)

ABOUT PROMPT PRAXIS LABORATORIES

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high-quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients. Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost-effective solutions that ensure safe, effective drug products. Join PPL and build a career defined by excellence and impact.

POSITION DESCRIPTION

. The Quality Assurance Associate II supports PPL's quality assurance program by performing independent scientific review of laboratory testing data generated by analytical chemistry laboratories operating in a cGMP-regulated environment. This role applies strong scientific understanding, regulatory knowledge, and data integrity principles to ensure laboratory testing records are accurate, compliant, and defensible prior to release of results to clients. The QA Associate II collaborates closely with QC analysts, laboratory leadership, and cross-functional teams to verify that testing activities adhere to approved methods, SOPs, and regulatory requirements. This position is ideal for candidates with experience in analytical chemistry who are interested in applying their scientific expertise in a quality assurance capacity.

PRIMARY RESPONSIBILITIES

Quality Assurance Data Review Perform independent review of analytical chemistry testing records to ensure compliance with cGMP requirements and internal quality systems. Verify accuracy, completeness, and integrity of laboratory data packages including raw data, calculations, chromatograms, worksheets, and supporting documentation. Confirm that testing was performed according to approved methods, SOPs, and client specifications. Ensure proper documentation of laboratory activities, deviations, and corrections in accordance with regulatory expectations. Review analytical data generated from analytical instrumentation to confirm accuracy and method compliance. Verify instrument methods, chromatographic conditions, and run parameters align with approved analytical methods. Confirm correct columns, standards, reagents, and solutions were used during testing. Ensure analytical calculations, dilution factors, and assay determinations are accurate and consistent with method requirements. Data Integrity & Regulatory Compliance Ensure laboratory documentation complies with cGMP and ALCOA+ data integrity principles. Review laboratory records for completeness, accuracy, and contemporaneous documentation. Verify audit trail compliance and ensure no unauthorized data modifications occur. Escalate potential deviations, laboratory investigations, or non-conformances when identified during review. Support laboratory readiness for regulatory inspections and client audits. Collaboration & Continuous Improvement Collaborate with Quality Assurance, QC laboratory teams, and Operations to support efficient and compliant testing workflows. Communicate review findings clearly and professionally to laboratory personnel. Participate in continuous improvement initiatives focused on strengthening laboratory quality systems and operational efficiency. Support development and improvement of SOPs, data review processes, and quality documentation practices. Contribute to maintaining a strong culture of quality and scientific integrity within the laboratory.

DESIRED QUALIFICATIONS

Bachelor's degree in Chemistry, or a related life science discipline. 3-5 years of experience working in a cGMP-regulated laboratory environment Strong experience with HPLC/UPLC, chromatography systems, analytical software (e.g., Empower), and Excel-based calculations and data analysis Deep understanding of analytical methods and laboratory workflows Strong knowledge of cGMP, FDA, and ICH guidelines Ability to interpret complex data and assess impact on results Effective written and verbal communication skills. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook). Ability to manage multiple priorities in a fast-paced laboratory environment. Ability to work independently while collaborating effectively with cross-functional teams

Pay:

$65,000.00 - $75,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person