Shift Operations & Deviation Specialist

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Plan with Match

Paid Time Off

Job summary

Simtra BioPharma Solutions is seeking an Operations Support Specialist to partner with Manufacturing and Quality on the 2:30pm–11pm shift. You will author deviations, drive CAPA actions, and support continuous improvement across aseptic manufacturing processes.

The role requires a Bachelor’s degree in Life Sciences or Engineering, strong written communication, and the ability to coordinate with multiple functions to ensure compliant, timely investigations and defect resolution.

Qualifications

• Bachelor's degree required or equivalent experience.
• Strong written communication to translate complex events into investigations.
• Experience working with Manufacturing, QA, SMEs in a fast-paced environment.
• Ability to manage multiple investigations and CAPA actions concurrently.

Responsibilities

• Lead on-shift deviation event response with Manufacturing and QA.
• Capture event details, initiate deviation investigations, and ensure timely handoffs.
• Write clear investigations with root cause analysis and CAPA rationale.
• Coordinate with multiple SMEs to close deviations and CAPAs.
• Support continuous improvement actions to enhance manufacturing reliability.

Skills

Written communication

Cross-functional collaboration

Quality systems

On-shift problem solving

Education

Bachelor's degree in Life Sciences or Engineering

Job description

Simtra BioPharma Solutions is seeking an Operations Support Specialist to partner with Manufacturing and Quality on the 2:30pm–11pm shift. You will author deviations, drive CAPA actions, and support continuous improvement across aseptic manufacturing processes.

The role requires a Bachelor’s degree in Life Sciences or Engineering, strong written communication, and the ability to coordinate with multiple functions to ensure compliant, timely investigations and defect resolution.