Science and Compliance Specialist, Weekend PM

The role

The Science and Compliance Specialist serves as an operations SME providing technical guidance on aseptic practices and equipment. This person leads investigations for deviations in an aseptic pharmaceutical manufacturing environment and drafts controlled documents.

What you will do

• Lead and execute investigations for deviations
• Determine problem-solving technique elements using investigation tools
• Investigate root cause and document results
• Maintain investigation records with accurate information
• Collaborate with Action Owners to create CAPA plans
• Manage multiple investigations simultaneously
• Represent operations during audits and inspections
• Review and analyze operational data to identify trends
• Partner with Process Engineers and Operational Excellence teams
• Draft, revise, and approve SOPs and controlled documents

Required qualifications

• BS degree
• 2+ years technical writing experience
• Knowledge of GMPs and worldwide regulatory agency guidelines
• Knowledge of applicable CAPA procedures, specifications, regulations and standards
• Microsoft Office Suite intermediate proficiency
• Goal-setting, prioritize, organization, attention to detail, and time management skills
• Critical & creative thinking and problem-solving skills
• Ability to use logic and scientific principles to reach conclusions
• Strong oral and written communication skills
• Ability to demonstrate strong leadership skills
• Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
• Ability to utilize enterprise software systems (Veeva)

Nice to have

• BS degree preferably in a science or technical area
• 2+ years technical writing experience preferably in pharmaceutical industry

Benefits

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave

About the company

Simtra BioPharma Solutions is a Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies. They offer delivery systems including pre-filled syringes, vials, and sterile crystallization.