Quality Specialist - REMOTE

Proclinical seeking a remote Quality Specialist for a leading biotech company.

The Quality Specialist is responsible for performing multiple activities in support of GMP manufacturing with minimal supervision within a fast-paced environment.

Must be eligible to work in the US.

Job Responsibilities:

• Lead the documentation and training quality systems, acting as system administrator for our electronic document management system The CMC related documentation includes SOPs, batch record maintenance and issuance, executed batch records and facility related documentation
• Support product release activities for drug substance, intermediates, drug product, and finished good for all phases of development including review and approval of master batch records and executed records
• Coordinate with internal multidisciplinary team to investigate, and resolve deviations and investigations prior to lot release
• Assist onsite oversight/monitoring of manufacturing campaigns as appropriate
• Responsible for maintaining master batch records and ensuring manufacturing batch records are approved prior to runs
• Help maintain and improve current training program including working with functional leads to develop role-based training
• Additional functions and duties responsibilities as applicable

Skills and Requirements:

• Bachelor's degree with 3+ years of working with CMC documentation in a Quality Assurance environment is required. Previous work at a facility with on-site manufacturing and use of an EDMS are a plus. Ideal candidates will have cell therapy experience.
• Skilled at navigating, executing tasks in, and troubleshooting an EDMS
• Presents solid understanding of quality assurance concepts and practices
• Knowledge of GMP manufacturing documentation requirements
• Displays effective communication skills (written and verbal)
• Demonstrates proactive thinking and actions
• Ability to work with a variety of experience levels in document management
• Direct Veeva Vault (QualityDocs) experience is a plus

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at +(1) 617-830-1627 or e.coly@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-EC1

INDCQA