USA - Documentation Specialist I (Manufacturing/Quality) (contract)

Responsibilities

• Track and review manufacturing batch records to ensure compliance with regulatory requirements
• Follow up with Manufacturing Technicians to ensure corrections are completed in a timely manner
• Maintain error tracking metrics to identify and address repeated violations of GDP
• Coach shopfloor technicians on GDP principles and best practices as applicable
• Identify and escalate GDP issues that could affect the safety, efficacy, and quality of drug substance
• Review batch record structure and recommend simplifications to minimize errors as applicable
• Ensure batch record review cycle times are met consistently
• Participate in deviation investigations and CAPA creation as applicable

Requirements

• Strong experience with CAPA processes, batch record review, and technical writing
• Proficiency in using documentation and quality management systems to locate errors and manage change action requirements
• Familiarity with ERP systems and electronic documentation platforms
• Knowledge of quality systems and GDP requirements within a pharmaceutical or biotechnology setting
• Excellent attention to detail with the ability to work quickly and accurately under pressure
• Strong interpersonal and information-gathering skills with the ability to work effectively in a team environment

Qualifications

• High School Diploma with a minimum of 5 years of relevant experience, or Associate's Degree with a minimum of 3 years of relevant experience, or Bachelor's Degree with a minimum of 1 year of relevant experience, including final batch record review
• Experience with pharmaceutical or biotechnology industry
• Experience with CAPA processes, batch record review, and technical writing
• Experience using documentation systems and quality management platforms