- • Write Validation Protocols and Reports per site SOPs using standard templates
• Route documents through documentation system for review and approval
• Author Change Controls for the implementation of new instrumentation and current instrument configuration changes
• Review documentation from external vendors related to instrument repairs and qualifications
• Help Scientists prepare/format PowerPoint presentations
• Develop and establish processes in Analytical to increase productivity
• Help author BOP/SOPs, CMC documents (formatting, proper meta data)
• Perform analytical testing on raw materials, intermediate batches, packaging and finished products as required.
• Data analysis and entry of test results. Investigate out of specification results.
• Support method development, validation and/or product transfer activity as necessary.
• Maintain, calibrate, and validate laboratory equipment.
• Ensures that GMP, Quality, Healthy & Safety are considered in all aspects of role.
• Investigate out of specification an out of trend data and recommend CAPA.
• Participate on cross-functional teams.
• Comply with all safety procedures and policies.
• Flexibility to work extended hours (including weekends) to archive results as needed.
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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