Overview
On Site
$33.33 - $36.1 hr
Contract - W2
Contract - Independent
Contract - 9+ mo(s)
Skills
GMP
GDP
SMARTSHEET
SMART SHEET
SOP
STANDARD OPERATING
BATCH RECORDS
BATCH RECORD
VALIDATION PROTOCOLS
TECHNICAL DOCUMENTS
TECHNICAL WRITING
DOCUMENT
Job Details
Payrate: $33.33 - $36.10/hr.
Summary:
Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, considering usability and ensuring accuracy, consistency and quality. Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.)
Responsibilities:
Nice to have:
Skills:
Top 3 Skill:
Experience:
Pay Transparency: The typical base pay for this role across the U.S. is: $33.33 - $36.10/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Summary:
Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, considering usability and ensuring accuracy, consistency and quality. Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.)
Responsibilities:
- Documentation Creation and Maintenance: Develop, write, and maintain standard operating procedures (SOPs), batch records, validation protocols, and other technical documents.
- Compliance: Ensure all documentation meets GMP standards and regulatory requirements, including FDA, EMA, and other relevant authorities.
- Collaboration: Work closely with cross-functional teams including Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs to gather necessary information and ensure accuracy in documentation.
- Review and Edit: Review and edit technical documents to ensure clarity, consistency, and completeness.
- Training Materials: Develop training materials (training qualification documents and answer keys) to assist in the onboarding and continuous education of plant personnel.
- Support Audits: Provide documentation support during internal and external audits and inspections.
- Continuous Improvement: Participate in continuous improvement initiatives to enhance documentation processes and systems.
- Go to the manufacturing floor, as required, to learn Mfg. processes when writing SOPs
Nice to have:
- Previous Pharma or biotech experience.
- Preferably in pharma manufacturing.
Skills:
- MS Office expertise
- Smart Sheets expertise
- Previous technical writing experience
- Regulated environment experience
- Document version control experience
- Excellent communication/writing skills
Top 3 Skill:
- Mastery of Microsoft Word program
- GMP and GDP
- Smartsheet
Experience:
- B.S. 2-3+ Years of experience
Pay Transparency: The typical base pay for this role across the U.S. is: $33.33 - $36.10/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.