Associate QC Specialist

Frontage Laboratories•Exton, PA

12d•Onsite

About The Position

The Associate QC Specialist supports quality control activities for large molecule bioanalytical studies, including PK, PD, ADA, and NAb, in a GLP-regulated contract research organization environment. The role independently reviews bioanalytical data, laboratory documentation, and study reports to ensure accuracy, completeness, and compliance with SOPs, GLP, and sponsor requirements. It also supports data-table preparation and quality control for clinical and regulatory reports, helping ensure the integrity of data delivered to clients.

Requirements

Bachelor’s degree in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or a related life sciences discipline.
For the Associate QC Specialist level: BS or MS in a life science and 0–2 years of experience in a bioanalytical laboratory, such as PK, ADA/immunogenicity, or PD/biomarker assays, or in a quality control role in a CRO, pharmaceutical, or biotechnology environment.
Familiarity with bioanalytical workflows such as PK, PD, ADA, and NAb, including ligand-binding assays, ELISA, multiplex immunoassays, molecular assays, or emerging biomarker platforms.
Experience reviewing scientific reports, analytical datasets, and laboratory documentation.
Knowledge of LIMS systems and electronic laboratory documentation practices.
Proficiency with Microsoft Excel, Word, and data formatting tools for dataset preparation.
Strong attention to detail and focus on data accuracy and integrity.
Ability to review complex datasets and identify inconsistencies.
Strong written and verbal communication skills.
Ability to manage multiple priorities in a fast-paced CRO environment.
Strong collaboration skills when working with cross-functional teams.

Nice To Haves

Experience with GLP-regulated studies or regulated documentation practices.

Responsibilities

Independently review biomarker bioanalytical data, including laboratory notebooks, raw instrument data, electronic files, and LIMS records.
Verify analytical data accuracy, traceability, completeness, and consistency with SOPs, GLP regulations, and study protocols.
Identify discrepancies or documentation gaps and coordinate with laboratory scientists and study teams to resolve them before final reporting.
Review method development, qualification, and validation reports for scientific accuracy and consistency across narrative text, tables, figures, and source data.
Review bioanalytical sample analysis reports for completeness, data integrity, and compliance with internal procedures and client requirements.
Confirm reported results are supported by verified raw data and documentation.
Prepare and QC bioanalytical result tables for clinical study reports and biomarker testing reports.
Review and interpret client Data Transfer Specifications (DTS) for formatting, variable definitions, and dataset structure.
Generate, QC, and transmit client-ready datasets and data tables according to sponsor specifications and project timelines.
Maintain data integrity and documentation supporting QC reviews for audit and inspection readiness.
Assist in maintaining standardized templates and QC checklists for report review.
Collaborate with laboratory scientists, project managers, data management teams, and quality assurance personnel to support timely reporting and client deliverables.
Communicate QC findings and track issue resolution to support high-quality final reports.
Support continuous improvement of QC processes and documentation standards.
Assist with preparation for internal audits and regulatory inspections.
Perform other duties as assigned.