QC Scientist - Level 1 US
Key Responsibilities Verify that analytical testing results are accurate and complete, recognizing deviations in test procedures, and/or SOPs. Write/review laboratory documents such as technical reports, analytical/microbiological test methods, specifications, SOPs validation documents, and transfer documents. Review and revise training materials. Identify training needs within staff.
Minimum Level of Education* B.Sc. Degree or equivalent experience
Job-Related Experience Demonstrated ability to participate in product projects. Command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations. Operational knowledge of analytical chemistry/microbiology (as applicable). Full understanding of the requirements and application of GMP principles in a laboratory environment. Effective verbal and written communication on an individual and group basis. Capability to assist with validation and transfer test methods as applicable. A demonstrated willingness to collaborate with colleagues to share best practices and /exchange ideas. Supports other teams when required. Technical expertise in a broad range of (bio)analytical methodologies, understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable). Experience reviewing development reports, batch records; 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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