Pharma Operations Support – Deviation & CAPA Lead

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with  

Paid Time Off

Paid Holidays

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking an Operations Support Specialist to partner with Manufacturing and Quality on shift. You will document deviations, lead CAPAs, and drive continuous improvement while ensuring compliance and patient safety.

The role focuses on capturing event details, initiating investigations, authoring deviations, coordinating cross-functional teams, and guiding return-to-production after incidents; typical workload includes writing three to four

Qualifications

• Bachelor's degree or equivalent experience in Life Sciences, Engineering, or related field.
• Strong written communication and collaboration across Manufacturing, QA, and support functions.
• Ability to work in a fast-paced, regulated manufacturing environment.

Responsibilities

• Document deviations on shift with accuracy and timeliness.
• Author and close manufacturing deviations (3–4 per month).
• Own and drive CAPA actions and CI activities related to manufacturing processes.

Skills

Strong written communication

Cross-functional collaboration

Attention to detail

Ability to work in fast-paced GMP env

Education

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

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking an Operations Support Specialist to partner with Manufacturing and Quality on shift. You will document deviations, lead CAPAs, and drive continuous improvement while ensuring compliance and patient safety.

The role focuses on capturing event details, initiating investigations, authoring deviations, coordinating cross-functional teams, and guiding return-to-production after incidents; typical workload includes writing three to four