Manufacturing Deviation & CAPA Specialist (3rd Shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 会社

Paid Holidays

Paid Time Off

Adoption Reimbursement Program

Education Assistance Program

Job summary

Simtra BioPharma Solutions is seeking an Operations Support Specialist to partner with Manufacturing and Quality on deviation handling and CAPA execution within an Operations Focus Factory. You will author investigations and drive timely closure while coordinating with cross-functional teams during incidents.

The role emphasizes compliant deviation documentation, data-driven root cause analysis, and continuous improvement to enhance manufacturing reliability and patient safety.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field; equivalent relevant experience may be considered.
• 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, technical 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

• Write and close approximately three to four deviations per month, depending on event volume and complexity.
• Own and drive assigned CAPAs and CI actions related to manufacturing processes and provide oversight of CAPA effectiveness.
• Lead or support continuous improvement actions to improve manufacturing reliability and right-first-time execution.
• Coach manufacturing colleagues on effective event detail capture, GDP expectations, deviation readiness, and prevention mindsets.

Skills

Strong written communication

Technical writing

Shift-based collaboration

Shop floor presence

Education

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

Job description

Simtra BioPharma Solutions is seeking an Operations Support Specialist to partner with Manufacturing and Quality on deviation handling and CAPA execution within an Operations Focus Factory. You will author investigations and drive timely closure while coordinating with cross-functional teams during incidents.

The role emphasizes compliant deviation documentation, data-driven root cause analysis, and continuous improvement to enhance manufacturing reliability and patient safety.