Technical Writer

Disability Solutions - Greenville, SC

Full-time - Entry Level

Greenville, SC

Administrative and Support Services

About the position

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. This position is responsible for collecting, organizing, formatting, and authoring Technical Services documents. The role will involve making inputs into the site inventory management system for Pre-Commercial Manufacturing activities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. In this role, you will work closely with Subject Matter Experts (SMEs) to gather the necessary information to create new Technical Services documents or update existing documents, such as Master Batch Records and protocols. You will also coordinate associated change control documents and review them with SMEs and Operations personnel to ensure accuracy, executability, and consistency in formatting. Maintaining an accurate documentation database and ensuring that inputs conform to company standards will be key responsibilities. Additionally, you will be responsible for closing out Technical Service help desk tickets related to document corrections and updates, providing requested information during client and FDA audits, and participating in cross-functional project development teams. You will also contribute to the continued implementation of electronic document software systems and perform other duties as assigned.

Responsibilities

• Work with Subject Matter Expert (SME) to gather information for new Technical Services documents or updates of existing documents.
• Coordinate associated change control documents.
• Review documents with SME and Operations personnel to ensure accuracy and consistency.
• Ensure the documentation database is accurate and inputs conform to company standards.
• Assist in making inputs to the Manufacturing Resource Planning for Technical Services manufacturing events.
• Close out Technical Service help desk tickets regarding document corrections and updates.
• Provide requested information during client and FDA audits.
• Participate in cross-functional project development teams.
• Contribute to the implementation of electronic document software systems.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in science or engineering with at least 1 year of relevant experience preferred; previous technical writing experience preferred.
• High School diploma or equivalent with at least 2 years of relevant industry experience; previous technical report writing preferred.
• Ability to administer quality system programs and resources.
• Familiar with GMP documentation requirements.
• Proficient with Microsoft Office Word and Excel and Adobe.
• Experience with database management software.
• Effective presentation/communication skills and project/resource management skills.
• Demonstrated ability to handle multiple priorities.

Nice-to-haves

• Experience in a pharmaceutical or biopharmaceutical environment.
• Familiarity with electronic document management systems.

Benefits

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes