QA Specialist - Level 1 US
Key Responsibilities Coordination and maintenance of Quality Management System (QMS) Gap analysis, interfacing with site SMEs for QMS Gap analysis completion, disseminating and evaluating recommended assessment levels for identified gaps. Develop and/or revise, coordinate the implementation of standard operating procedures, guidances and/or instructions.
Minimum Level of Education* B.Sc. Degree or equivalent experience
Job-Related Experience Experience with technical writing, formatting skills (specifically, SOPs, working instructions, guidances, etc.) is a must. Command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations. Experience with documentation and knowledge management (electronic document management systems); training curricula implementation/revision; training delivery (writing quizzes, classroom training…). Experience of working in teams to improve processes or resolve problems. Knowledge of data integrity requirements. Experience with data review (analytical reports, batch records, investigations, development reports and raw data), working with CDMOs is a plus.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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