Deviation & CAPA Operations Specialist

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 公司

Paid Holidays

Paid Time Off

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana is seeking an Operations Support Specialist to partner with manufacturing shifts and support deviation events. The role involves writing deviations, initiating investigations, and driving CAPA actions to improve processes and ensure compliant returns to production.

The position requires collaboration across Manufacturing, QA, Engineering, and other SMEs, with shift coverage during 2:30pm–11pm, Monday to Friday, on-site at our Bloomington

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• Ability to work assigned shift coverage, including 2nd shift, 3rd shift, Weekend AM, or Weekend PM as assigned by business need.
• Strong written communication skills with the ability to translate complex manufacturing events into clear, factual narratives.
• Demonstrated ability to work effectively with Manufacturing, QA, SMEs, and site support functions in a fast-paced production environment.
• Ability to execute multiple investigations and CAPA actions while maintaining attention to detail, compliance, safety, and product quality.

Responsibilities

• Author manufacturing deviations and close approximately three to four deviations per month.
• Own and drive assigned CAPA actions related to manufacturing processes and ensure CAPA effectiveness.
• Maintain investigation records, CAPA records, and supporting documentation, inspection-ready.
• Support deviation investigations and ensure timely initiation of investigation processes.

Skills

Strong written communication

Team collaboration

Problem solving

Attention to detail

Education

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

Job description

Simtra BioPharma Solutions in Bloomington, Indiana is seeking an Operations Support Specialist to partner with manufacturing shifts and support deviation events. The role involves writing deviations, initiating investigations, and driving CAPA actions to improve processes and ensure compliant returns to production.

The position requires collaboration across Manufacturing, QA, Engineering, and other SMEs, with shift coverage during 2:30pm–11pm, Monday to Friday, on-site at our Bloomington