Senior Scientific QA & Regulatory Specialist

Charles River Laboratories, Inc.; Shrewsbury, Northern (MA, KY); Hybrid; USD 100,289,000 - 108,886,000; Full time

Job summary

Charles River Laboratories, Inc. is seeking a qualified QA/Regulatory Data Professional in Massachusetts to oversee regulatory compliance for assigned studies and provide data support to sponsors. You will manage QC reviews, generate analyses, and maintain study documentation to meet SOPs and CID requirements.

The role requires 3–5 years in biology/chemistry lab settings, a B.S. degree, and strong MS Office skills. Occasional overtime and post-award/pre-study meetings may be required.

Qualifications

• Bachelor’s degree (B.A./B.S.) or equivalent in related discipline required.
• Three to Five years related experience in biology, chemistry/pharmacy, or similar lab environment. GLP experience preferred.
• Certification/Licensure: None.
• Other: This position requires analytical thinking, strong organizational skills, and proficiency with MS Office and database management. Knowledge of GLP and study design.

Responsibilities

• Create, customize, and monitor planning tools to facilitate prioritization of daily activities (i.e., Smartsheet, RPM, M-files, etc.).
• Maintain study and inventory trackers in support of departments.
• Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor requests for information and tables, and assist with sponsor on-site visits.
• May serve as primary point of contact to the sponsor when project scientist is not available.
• Perform and document QC review of study data and audit trails with minimal errors, while identifying process improvements.
• Independently generate special tables/files to support sponsor analysis.
• Ensure study books are corrected and documented prior to QA submission.
• Document deviations from protocol/SOPs and assist in drafting study-specific SOPs.
• Review and document all study data in compliance with standards and methods.
• Maintain effective communication with peers, supervisor, team and Sponsor/Project Scientist.
• Ensure documents align with CID requirements.
• Assist with QA audits and follow-up actions.
• Attend post-award or pre-study meetings as needed and monitor events during in-life phase.
• Develop and update QC guidance documents, SOPs, and data check forms.
• Assist with generating results and presenting study data.
• Recommend SOP changes to avoid deviations in collaboration with lab management.
• Develop training programs and mentor staff on QC practices.
• Teach and mentor personnel on proper QC practices.
• On an as-needed basis, work overtime, weekends and shifts as required.
• The pay for this position is between $35.00 - $38.00/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Skills

Regulatory compliance

Quality Assurance

Documentation

QC audits

Communication

MS Office

SOPs

Data management

Education

Bachelor’s degree in life sciences or related field

Tools

Smartsheet

RPM

M-files

Excel

Job description

Charles River Laboratories, Inc. is seeking a qualified QA/Regulatory Data Professional in Massachusetts to oversee regulatory compliance for assigned studies and provide data support to sponsors. You will manage QC reviews, generate analyses, and maintain study documentation to meet SOPs and CID requirements.

The role requires 3–5 years in biology/chemistry lab settings, a B.S. degree, and strong MS Office skills. Occasional overtime and post-award/pre-study meetings may be required.