Location:    Remote

Technical Documentation Specialist

Position Summary:

• The Technical Documentation Specialist provides professional expertise supporting Client's business objectives.
• The role partners with cross-functional stakeholders to deliver high-quality work, apply functional best practices, and drive operational excellence within the assigned area.

Key Responsibilities:

• Execute responsibilities aligned with the functional discipline and business priorities.
• Partner with internal stakeholders to plan, coordinate, and deliver work products.
• Analyze information and recommend practical solutions.
• Maintain documentation, reporting, and compliance with applicable policies.
• Identify opportunities for continuous improvement.
• Communicate project status, risks, and issues proactively.

Required Qualifications:

• Relevant experience in this functional area.
• Excellent communication and stakeholder management skills.
• Strong analytical and organizational abilities.
• Ability to manage multiple priorities independently.

Preferred Qualifications:

• Life sciences, biotechnology, or pharmaceutical industry experience where applicable.
• Experience with enterprise business systems and modern collaboration tools.

Technical Skills:

• Demonstrated proficiency with technologies commonly used within the Technical Documentation Specialist discipline.
• Microsoft 365 proficiency.

Core Competencies:

• Collaboration
• Accountability
• Critical Thinking
• Customer Focus
• Continuous Improvement

Batch Record Review:

Position Summary:

• The Batch Record Review provides professional expertise supporting Client's business objectives.
• The role partners with cross-functional stakeholders to deliver high-quality work, apply functional best practices, and drive operational excellence within the assigned area.

Key Responsibilities:

• Execute responsibilities aligned with the functional discipline and business priorities.
• Partner with internal stakeholders to plan, coordinate, and deliver work products.
• Analyze information and recommend practical solutions.
• Maintain documentation, reporting, and compliance with applicable policies.
• Identify opportunities for continuous improvement.
• Communicate project status, risks, and issues proactively.

Required Qualifications:

• 5 years of relevant experience in this functional area.
• Manufacturing experience.
• Excellent communication and stakeholder management skills.
• Strong analytical and organizational abilities.
• Ability to manage multiple priorities independently.
• BS degree in relevant field

Preferred Qualifications:

• Life sciences, biotechnology, or pharmaceutical industry experience where applicable.
• Experience with enterprise business systems and modern collaboration tools.
• BS in chemistry or chemical engineering.

Required Technical Skills:

• Demonstrated proficiency with technologies commonly used within the Batch Record Review discipline.
• Microsoft 365 proficiency.

Core Competencies:

• Collaboration
• Accountability
• Critical Thinking
• Customer Focus
• Continuous Improvement

Business Need:           Assisting with review of executed batch records for commercial drug substance production.