Dossier Quality Control

Job Title: Dossier Quality Control

Location: Fully Remote (Some on-site presence in Norton, MA, and Cambridge, MA, as needed).

Contract – 9 Month(s)

Pay Range : $60/hr. - $66.64/hr on w2 without benefits.

Overview

Client is seeking an Analyst IV, Dossier Data Integrity in Quality Control Operations (Contractor) to ensure compliance with high-quality standards in support of commercialization efforts. This role is responsible for verifying the accuracy, completeness, and consistency of regulatory filings, laboratory data, and reports.

The position is fully remote, though some on-site presence in Norton, MA, and Cambridge, MA, as well as travel to CMO/CTL sites, may be required.

Key Responsibilities

• Ensure data integrity and traceability by reviewing regulatory dossier sections against reference methods and reports.
• Verify accuracy and transcription of analytical data, ensuring completeness and correct documentation of associated references.
• Review laboratory documentation, including notebooks, worksheets, logbooks, and electronic data, ensuring compliance with SOPs and current Good Manufacturing Practices (cGMP).
• Examine audit trails to confirm electronic data compliance with procedural guidelines.
• Identify and resolve discrepancies in analytical data and reports, collaborating with relevant stakeholders.
• Work closely with management and clients to address necessary corrections and continuous improvements in the review process.
• Provide insights and recommendations to enhance review procedures and streamline workflow.
• Perform additional tasks as assigned by management.

Qualifications

• Bachelor’s degree in chemistry, Biology, Biochemistry, or a related scientific field.
• 5 years of experience in a GMP Quality Control function within the pharmaceutical/biotech industry (or equivalent relevant experience).
• Strong knowledge of analytical method transfer, validation, verification, and implementation within a method lifecycle management framework.
• Proficiency in technical writing, with experience drafting and reviewing investigations preferred.
• Excellent data analysis, problem-solving, and decision-making skills with high attention to detail.
• Experience conducting investigations and implementing Corrective and Preventive Actions (CAPA).
• Strong organizational skills, capable of managing multiple tasks efficiently and autonomously.
• Excellent communication and teamwork abilities, with a proven ability to collaborate effectively in a cross-functional environment.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.