Aptask Global Workforce (AGW) is seeking a Technical Writer for an Onsite position with a Global Biotechnology Company located in New Albany, OH. This is a 24+ month contract opportunity. 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 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/revised training documentation for manufacturing staff
- Support process owners and participate in continuous process improvement and/or troubleshooting projects
- 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
Requirements: - Master's Degree in Science and/or Engineering
- OR Bachelor's Degree in Science and/or Engineering and 2 years of experience in Manufacturing, Packaging, or Quality in pharmaceutical, medical device, or biotechnology companies
- OR Associate's Degree in Science and/or Engineering and 5 years of experience in Manufacturing, Packaging, or Quality in pharmaceutical, medical device, or biotechnology companies
- OR High School Diploma / GED and 8 years of experience in Manufacturing, Packaging, or Quality in pharmaceutical, medical device, or biotechnology companies
- Experience working in a Good Manufacturing Practices (GMP) environment
- Prior deviation and investigation ownership experience
- Excellent written and oral communication skills
Desired skills: - Previous Veeva experience
- Prior deviation and CAPA experience
- Experience with device assembly and packaging of final product
- Ability to translate highly technical information into easily understandable information for manufacturing operators
- A fact-based problem solver with strong troubleshooting and problem-solving skills
Pay range: up to $38.21 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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