Pharma Operations Support Specialist - Deviation & CAPA

Simtra-Biopharma-Solutions; Bloomington (IN); In loco; USD 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Simtra BioPharma Solutions in Bloomington, Indiana, seeks an Operations Support Specialist to partner with Manufacturing and Quality on deviation events and investigations. You will capture critical event details, write clear investigation narratives, and coordinate cross-functional actions to restore operations quickly and compliantly.

The role emphasizes data-driven analysis, CAPA execution, and focus factory collaboration to improve process reliability and aseptic practices.

Competenze

• Bachelor's degree in Life Sciences, Engineering, or related field.
• Ability to work shift coverage, including weekends as assigned.
• Strong written communication skills for clear, factual investigation narratives.
• Demonstrated ability to collaborate with Manufacturing, QA, SME colleagues in a fast-paced production environment.
• Ability to manage multiple investigations and CAPA actions with attention to detail, safety, and product quality.

Mansioni

• Partner with Manufacturing and QA to document events and impacts.
• Capture event details such as timing, equipment state, batch identifiers, and parameters.
• Support initiation of deviation investigations and handoffs across shifts.
• Coordinate with cross-functional teams to return operations to normal after incidents.
• Author investigations with event chronology, root cause analysis, and corrective actions.
• Use root cause tools such as 5 Whys and Ishikawa to analyze deviation complexity.
• Drive deviations to timely closure, coordinating input from multiple functions.
• Identify recurring themes for Continuous Improvement actions.
• Own and execute CAPA actions related to manufacturing processes and documentation.
• Lead continuous improvement to improve reliability, right-first-time, and GMP compliance.

Conoscenze

Written communication

Cross-functional collaboration

Attention to detail

Problem solving

Formazione

Bachelor's degree in Life Sciences, Engineering, or related field

Descrizione del lavoro

Simtra BioPharma Solutions in Bloomington, Indiana, seeks an Operations Support Specialist to partner with Manufacturing and Quality on deviation events and investigations. You will capture critical event details, write clear investigation narratives, and coordinate cross-functional actions to restore operations quickly and compliantly.

The role emphasizes data-driven analysis, CAPA execution, and focus factory collaboration to improve process reliability and aseptic practices.