Associate QC Specialist
Frontage Laboratories
Summary
The QC Specialist supports quality control activities for large molecule (PK, PD, ADA, NAb, etc.) bioanalytical studies conducted in a GLP-regulated contract research organization (CRO) environment. This role is responsible for the independent quality review of bioanalytical data, laboratory documentation, and study reports to ensure accuracy, completeness, and compliance with Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP), and sponsor requirements.
Job description
Job Summary
The QC Specialist supports quality control activities for large molecule (PK, PD, ADA, NAb, etc.) bioanalytical studies conducted in a GLP-regulated contract research organization (CRO) environment. This role is responsible for the independent quality review of bioanalytical data, laboratory documentation, and study reports to ensure accuracy, completeness, and compliance with Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP), and sponsor requirements.
Key Responsibilities
- Perform independent quality control review of biomarker bioanalytical data including laboratory notebooks, raw instrument data, electronic files, and LIMS records.
- Verify accuracy, traceability, completeness, and consistency of analytical data in accordance with SOPs, GLP regulations, and study protocols.
- Identify discrepancies or documentation gaps and work with laboratory scientists and study teams to resolve issues prior to final reporting.
- Review method development, qualification, and validation reports to ensure scientific accuracy and consistency between narrative text, tables, figures, and source data.
- Review bioanalytical sample analysis reports for completeness, data integrity, and compliance with internal procedures and client requirements.
- Prepare and QC bioanalytical result tables for clinical study reports and biomarker testing reports.
- Review and interpret client Data Transfer Specifications (DTS) to ensure correct formatting, variable definitions, and dataset structure.
- Generate, QC, and transmit client-ready datasets and data tables according to sponsor specifications and project timelines.
- Maintain documentation supporting QC review processes for audit and inspection readiness.
- Assist in maintaining standardized templates and QC checklists to support efficient report review.
- Collaborate with laboratory scientists, project managers, data management teams, and quality assurance personnel to support timely study reporting and client deliverables.
- Support continuous improvement initiatives for QC processes and documentation standards.
- Assist with preparation for internal audits and regulatory inspections.
Qualifications
Bachelor's degree in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or a related life sciences discipline.
Associate QC Specialist: BS/MS in a life science with 0-2 years of experience in a bioanalytical laboratory (e.g., PK, ADA/immunogenicity, or PD/biomarker assays) or a quality control role in a CRO, pharmaceutical, or biotechnology environment.
Familiarity with PK, PD, ADA, NAb, etc. bioanalytical workflows (e.g., 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.
Requirements
- Bachelor's degree in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or a related life sciences discipline
- 0-2 years of experience in a bioanalytical laboratory or a quality control role in a CRO, pharmaceutical, or biotechnology environment
- Familiarity with PK, PD, ADA, NAb bioanalytical workflows (e.g., ligand-binding assays, ELISA, multiplex immunoassays)
- 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
- Strong attention to detail with a focus on data accuracy and data integrity
- 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
Benefits
- Health Insurance
- Dental Insurance
- 401(k) Plan
- Disability Insurance
- Life Insurance
Company overview
Frontage Laboratories is a leading global Contract Research Organization (CRO) established in 2001 and headquartered in Exton, Pennsylvania. As an FDA-registered and inspected pharmaceutical development organization, Frontage provides comprehensive, science-driven services throughout the entire drug discovery and development lifecycle. The company operates 26 state-of-the-art facilities across North America, Europe, and Asia, serving biotechnology and pharmaceutical clients of all sizes. Frontage's integrated service portfolio includes drug discovery, drug metabolism and pharmacokinetics (DMPK), preclinical safety and toxicology, formulation development and manufacturing, analytical and bioanalytical testing, clinical trials, and central laboratory services. With over 1,800 employees worldwide, the company has established itself as a strategic partner in advancing innovative therapies from early discovery through regulatory submissions and commercialization. Frontage's expertise spans small molecules, biologics, cell and gene therapies, and agrochemicals, supported by GLP/GCP-compliant operations and a robust quality assurance framework that enables clients to navigate complex regulatory pathways in the US, EU, China, and other global markets.