Hiring: Science and Compliance Specialist, Weekend PM Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-12 13:51:41 Employment Type: Contract Target Skills & Keywords : C, Microsoft Excel, Microsoft Office, Microsoft PowerPoint About the job Experience: •2+ years technical writing experience, preferably in pharmaceutical industry Required Skills: •Lead and execute investigations for deviations, including defining scope, applying structured problem‑solving methods, and documenting results in compliance with cGMP standards. •Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools •Investigate the root cause(s) of the issue and document the investigation results •Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle •Partner cross-functionally with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness •Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines •Represent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting data •Review and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiency Qualifications: •BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience •Knowledge of applicable CAPA procedures, specifications, regulations and standards •Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency •Goal-setting, prioritize, organization, attention to detail, and time management skills •Critical & creative thinking and problem-solving skills •Demonstrated capacity to use logic and scientific principles to reach conclusions when presented with ambiguous data •Strong oral and written communication skills •Demonstrated capacity to demonstrate strong leadership skills •Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP) •Demonstrated capacity to utilize enterprise software systems (Veeva) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!