Technical Writing Specialist

Location: New Albany, OH
Onsite Flexibility: Hybrid — fully onsite with occasional flexibility to work from home (1–2 days per week after 6 months)
Position Type: Contract (24 months)
Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. without sponsorship.

About the Role

In this role, you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOPs), protocols, technical reports, and training material in a GMP-regulated environment that supports the manufacturing process.

Responsibilities

• Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols, and reports for the manufacturing team.
• Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data, and tracking of technical documents.
• Liaise with the manufacturing team and other cross-functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new or revised training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and/or troubleshooting projects.
• Support the manufacturing team in reducing document turnaround times.
• Ensure documentation-related actions are completed on time, and the current schedule is maintained, accurate, and up to date.
• Develop protocols for Manufacturing to support change controls, deviations, and troubleshooting investigations with input from relevant SMEs.
• Generate, own, and provide subject matter expertise to Quality System records, such as minor deviations, CAPA, and change control records.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
• Share knowledge with members of the manufacturing team.

Requirements

• GMP background
• Prior deviation/investigation ownership
• Excellent written and oral communication

Qualifications

Education

• Master's Degree in Science and/or Engineering; OR
• Bachelor's Degree in Science and/or Engineering and 2 years in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies; OR
• Associate's Degree in Science and/or Engineering and 5 years in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies; OR
• High School Diploma/GED and 8 years in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.

Educational background in Science and/or Engineering (preferred).

Experience

• Experience in Manufacturing, Packaging, or Quality within pharmaceutical, medical device, or biotechnology companies (years vary by education level — see Education Requirements).
• B.S. with 2 years of experience is the ideal candidate profile.

Preferred Skills

• Experience working in GMP pharma and/or biotechnology industry.
• Experience in a Good Manufacturing Practices (GMP) environment and demonstrated background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• Dynamic skills and usage of photographs, drawings, diagrams, animation, and charts that increase users' understanding.
• Experience supporting deviations, investigations, CAPAs, and change controls.
• Fact-based problem solver with strong troubleshooting and problem-solving skills.
• Proactive with the ability to prioritize work to meet benchmarks.
• Good documentation and communication.
• Previous Veeva experience.
• Prior deviation and CAPA experience.

Pay

$33.00–$37.00 / hour (USD)

Schedule

8:00 AM – 5:00 PM (Days)

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund