Operations Support Specialist: Deviations & CAPA Lead

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 Savings Plan with ‑‑

Paid Time Off

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, seeks an Operations Support Specialist to partner with manufacturing shifts and QA in deviation event response. You will author deviations, drive CAPA actions, and contribute to continuous improvement of aseptic and compliant operations.

The role requires strong written communication, GMP knowledge, and the ability to coordinate with multiple SMEs for timely investigations and exit readiness.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field; equivalent experience considered.
• Strong written communication skills; able to translate complex events into clear narratives.
• Experience with GMP documentation, deviation investigations, and CAPA execution.
• Ability to work with cross-functional teams in a fast-paced manufacturing environment.

Responsibilities

• Author manufacturing deviations and close 3–4 deviation per month.
• Own CAPA actions and CI initiatives related to manufacturing processes.
• Coordinate with Manufacturing, QA, Engineering and other SMEs to ensure timely, compliant investigations.
• Support on-shift deviation event response and ensure accurate event detail capture.
• Maintain inspection-ready documentation and support shift handoffs and reviews.

Skills

Written communication

GMP knowledge

CAPA ownership

Root cause analysis

Education

Bachelor's degree in Life Sciences or Engineering

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, seeks an Operations Support Specialist to partner with manufacturing shifts and QA in deviation event response. You will author deviations, drive CAPA actions, and contribute to continuous improvement of aseptic and compliant operations.

The role requires strong written communication, GMP knowledge, and the ability to coordinate with multiple SMEs for timely investigations and exit readiness.