Associate QC Specialist

                                                                  Associate QC Specialist/QC Specialist/Sr. QC Specialist – Large Molecule

Fulltime

Exton PA

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

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.

The position plays a key role in ensuring the integrity of data delivered to clients by reviewing analytical datasets, validating report content, and supporting preparation and quality control of data tables used in clinical and regulatory reports.

Key Responsibilities

Bioanalytical Data QC Review

• Perform independent quality control review of biomarker bioanalytical data including laboratory notebooks, raw instrument data, electronic files, and Laboratory Information Management System (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.

Study Report Review

• 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.
• Ensure reported results are supported by verified raw data and documentation.

Data Tables and Client Deliverables

• 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.

Data Integrity and Compliance

• Ensure all QC review activities maintain data integrity and meet regulatory expectations.
• Maintain documentation supporting QC review processes for audit and inspection readiness.
• Assist in maintaining standardized templates and QC checklists to support efficient report review.

Cross-Functional Collaboration

• Collaborate with laboratory scientists, project managers, data management teams, and quality assurance personnel to support timely study reporting and client deliverables.
• Communicate QC findings clearly and track issue resolution to ensure high-quality final reports.

Additional Responsibilities

• Support continuous improvement initiatives for QC processes and documentation standards.
• Assist with preparation for internal audits and regulatory inspections.
• Perform other duties as assigned.

Qualifications

Education

• Bachelor’s degree in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or a related life sciences discipline.

Experience and Qualification

• 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.

• QC Specialist: BS with 2–5 years (or MS with 1–3 years) of the experience above, including work in a regulated (GLP/GCLP/GxP) environment.
• Sr. QC Specialist: BS with 5+ years of QC experience in a CRO, pharmaceutical, or biotechnology environment, or 3+ years of experience as a scientist in a bioanalytical laboratory (e.g., PK, ADA/immunogenicity, or PD/biomarker assays) in a regulated (GLP/GCLP/GxP) setting.

• Experience with GLP-regulated studies or regulated documentation practices is preferred.

Technical Skills

• 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.

Core Competencies

• Strong attention to detail with a focus on data accuracy and data 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.

Salary and Benefits

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.