Aseptic Compliance Specialist - Weekend AM

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

Benefits offered by this job

Medical & Dental Coverage

FSA

Life Insurance

401(k) Plan with Company Match

Paid Holidays & PTO

Parental Leave

Adoption Reimbursement

Education Assistance

Employee Assistance Program

Employee Ownership Plan

Disability Insurance

Vision Coverage

Critical Illness Insurance

Accident Insurance

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Science and Compliance Specialist for weekend AM shifts. You will lead investigations for deviations, draft and revise SOPs, and support audits while ensuring accurate cGMP records and CAPA effectiveness.

You will partner with Process Engineers and Operational Excellence to drive improvements in safety, quality, and efficiency. Schedule: Friday–Sunday 7:00am–7:30pm; strong writing, problem solving, and communication skills are essential.

Qualifications

• BS degree in science or technical area (or equivalent aseptic pharmaceutical experience).
• 2+ years of technical writing experience, preferably in pharma.
• GMP awareness and regulatory guideline knowledge required.
• Experience with CAPA procedures and SOPs.

Responsibilities

• Lead and execute investigations for deviations, documenting results per cGMP.
• Define/Measure/Analyze aspects of investigations using proper tools.
• Determine root causes and document investigation results clearly.
• Maintain up-to-date investigation records and support CAPA effectiveness.

Skills

Technical writing

GMP knowledge

Root-cause analysis

Leadership

Communication

Time management

Problem solving

Education

BS in science/technical field

Tools

Veeva

MS Office

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Science and Compliance Specialist for weekend AM shifts. You will lead investigations for deviations, draft and revise SOPs, and support audits while ensuring accurate cGMP records and CAPA effectiveness.

You will partner with Process Engineers and Operational Excellence to drive improvements in safety, quality, and efficiency. Schedule: Friday–Sunday 7:00am–7:30pm; strong writing, problem solving, and communication skills are essential.