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Job Description
Simtra BioPharma Solutions is seeking a Principal Technical Writer to join their team in Bloomington, Indiana. This role is responsible for performing site Non-Conformance Report (NCR) and Significant SNCR investigations, authoring CAPAs, standard operating procedures (SOPs), Clinical Batch Records, and miscellaneous technical transfer documentation. The Principal Technical Writer will also support training for operators and collaborate with impacted departments to determine appropriate corrective or preventive actions.
The role involves:
- Developing the scope and approach for assigned CAPAs, NCRs, Batch Records, and technical documentation.
- Quantifying data to drive continuous improvement through document revisions and leadership.
- Providing relevant experience for training manufacturing and technical personnel.
- Establishing a scalable framework and organization for technical and quality documentation.
- Identifying cross-functional team members and assembling investigation/authoring teams.
- Investigating the root cause(s) of issues and documenting investigation results.
- Collaborating with Action Owners to develop Action and Effectiveness Plans.
- Presenting in Quality Review Board (QRB) stages.
- Managing multiple investigations and speaking to clients and regulatory authorities.
Requirements:
- BS degree in a science or technical area or equivalent experience.
- 5+ years of technical writing experience, preferably in the pharmaceutical industry.
- Knowledge of applicable CAPA procedures, specifications, regulations, and standards.
- Proficiency in Microsoft Office Suite.
- Strong goal-setting, prioritization, organization, and time management skills.
- Critical and creative thinking and problem-solving skills.
- Strong oral and written communication skills.
- Knowledge of FDA regulations and Good Manufacturing Practices (GMP).
- Ability to utilize enterprise software systems (Trackwise).
Simtra BioPharma Solutions offers:
- Day One Benefits including Medical & Dental Coverage, Flexible Spending Accounts, and Life Insurance.
- 401(k) Retirement Savings Plan with Company Match.
- Time Off Program, Paid Holidays, Paid Time Off, and Paid Parental Leave.
- Adoption Reimbursement Program and Education Assistance Program.
- Employee Assistance Program and Community and Volunteer Service Program.
- Employee Ownership Plan.
- Onsite Campus Amenities including a Workout Facility and Cafeteria.
