Technical Writing Specialist

Location: New Albany OH

Onsite Flexibility: Hybrid fully onsite with occasional flexibility to work from home (12 days per week after 6 months)

• Position Type: Contract
• Contract Duration: 24 months
• Pay Rate: $33.00$37.00 / Hour (USD)
• Shift / Schedule: 8 AM 5 PM (Days)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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

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• Develop review and update technical content including but not limited to standard operating procedures work instructions risk assessments protocols & reports for the manufacturing team.
• Provide technical and clerical support to the manufacturing team in preparing documentation collating data and tracking 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/revise training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and/or troubleshooting projects.
• Support 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 & 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.

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• GMP background demonstrated experience in a Good Manufacturing Practices environment
• Prior deviation/investigation ownership
• Excellent written and oral communication

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• Experience working in the 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.
• A 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.
• Educational background in Science and/or Engineering.

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Basic Qualifications (one of the following):

• Masters Degree in Science and/or Engineering.
• Bachelors Degree in Science and/or Engineering and 2 years of Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.
• Associates Degree in Science and/or Engineering and 5 years of Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.
• High School Diploma/GED and 8 years of Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.

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• Minimum 2 years of Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies (with Bachelors Degree); or 5 years with Associates Degree; or 8 years with High School Diploma/GED.
• Prior experience owning deviations and/or CAPA investigations.

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• B.S. with 2 years of experience is the ideal candidate profile.
• Prior experience in the GMP pharma and/or biotechnology industry.
• Experience with device assembly and packaging of final product.
• Experience supporting deviations investigations CAPAs and change controls.

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

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GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking financial services technology life sciences biotech utilities and retail sectors throughout the U.S. and Canada.

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Job Number: 26-13579

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