Performs a wide variety of QA activities to ensure compliance with applicable regulatory requirements
Assists with GMP internal and external audits.
Assists with training programs.
Performs batch records review.
Perform disposition of product.
Coordinates data and documentation review and analysis.
Processes deviations and non-conformances.
Writes documents, standard operating procedures and reports.
Represents department in cross-functional teams, projects and GXP-related problem resolution.
Uses professional concepts and company policies and procedures to solve a variety of problems.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Normally receives general instructions on routine work, detailed instructions on new assignments.
Typically 1 year related experience in cGMP/FDA regulated industry.
Bachelor’s degree in a scientific discipline or equivalent.
Proficient in MS Office applications.
Ability to gown aseptically for work in Clean Room environments.