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Catalent · 1 day ago

Technical Writer

Greenville, NC

Full-time

Onsite

Entry Level

1+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to improving health. The Technical Writer is responsible for collecting, organizing, formatting, and authoring documents, while ensuring that documentation complies with company standards and is accurate for manufacturing activities.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Work with Subject Matter Expert (SME) to gather the information needed to create new Technical Services documents or updates of existing documents (i.e. Master Batch Records and protocols) and coordinate associated change control documents

Review documents with SME and Operations personnel to ensure they are accurate, executable and the formatting is consistent and harmonized

Ensure the documentation database is accurate and inputs conform to company standards

Ensure and assist in making inputs to the Manufacturing Resource Planning in preparation for Technical Services manufacturing events

Responsible to close out Technical Service help desk tickets regarding Technical Service document corrections and updates

Provide requested information during client and FDA audits

Participate and contribute to the activities of the cross functional project development teams

Participate and contribute to the continued implementation of electronic document software system

All other duties as assigned

Qualification

GMP documentationTechnical writingDatabase managementQuality system programsCollaboration with SMEsDocument formattingChange control coordinationClient audit preparation

Required

Bachelor's degree in a Science-related field, Engineering or Industrial Technologies with at least 1 year of relevant experience preferred; previous technical writing experience preferred

Associate degree in a Science-related field, Engineering or Industrial Technologies with at least 2 years of relevant experience preferred; previous technical writing experience preferred

High school diploma or equivalent with at least 3 years of relevant industry experience; previous technical report writing preferred

Ability to administer quality system programs and resources

Familiar with GMP documentation requirements

Experience with database management software

Position requires the ability to occasionally lift 40 lbs unassisted, and occasionally push and pull a maximum of 100 lbs

Majority of workday is performed while sitting, standing, and walking

Requires the use of hands for simple grasping and fine manipulations

Ability to climb, bend, stoop, twist, and have full range of motion in upper and lower extremities

Occasional exposure to dust, fumes, gases, skin and respiratory irritants, moving machinery parts, and damp, humid and wet environments

Benefits

Competitive medical benefits and 401K

152 hours of PTO + 8 Paid Holidays

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (1)