- Remote - PST hours
- Job Terms:
- DOE + subsidized benefits
- Start date:
- Posted By:
- Debra Powell
This is a 1 year contract position with possible extension.
Position is responsible for the development, maintenance, and revision of Manufacturing Recipes and Documents (Batch Records, Standard Operating Procedures, Forms, Standard Records, Technical Reports) used by Production.
The incumbent will represent the department as a subject matter expert and liaison between Operations, Quality, Production Support and Engineering. Work with identified groups to maintain integrated solutions between recipes, documents, and supporting automation systems. Solve complex technical writing, editing, and recipe/document administration issues following cGMP regulations and company standards. Perform assigned tasks and work to achieve company goals and department objectives. Lead cross-functional teams in the resolution of business or systems issues.
Participate in Production initiatives by providing input on future technical system enhancements, business process updates, training initiatives, and document practices. Works to establish the templates, metadata and standards required for different document types to ensure consistency for end users. Facilitate workshops and conduct personnel interviews to maintain accurate and comprehensive understanding of current processes. Proofread and edit internal documents for consistency, effectiveness, and overall quality. Participate and provide support for continuous process improvement efforts; update internal documentation accordingly. Must be able to work in a team setting with team members face-to-face as well as in remote locations over multiple time zones.
-Ability to write technical documents, and tenacious attention to detail and consistency, especially with respect to style, format, and layout for visual design simplicity is a must.
-Previous experience with documents in a regulatory environment is preferred and knowledge or experience in the biotech or pharmaceutical manufacturing industry is beneficial.
-Proficiency in a broad range of technical skills, including expert-level use of Google Software, MS Excel, Word, Power Point, Visio is required and knowledge of document management systems (e.g. Condor and Veeva), quality systems (Veeva) and document collaboration systems (e.g. SmartSheets) are beneficial.
-An aptitude for teamwork and the ability to collaborate effectively with leaders, engineers and subject matter experts is needed.
-Strong organizational and time-management skills; the ability to deliver under pressure; and the ability to work flexibly to support changing assignments and priorities in an independent and reliable manner.
-Exceptional written and oral communication skills.
-Proven ability to create strong working relationships with respect to cultural diversity and working styles.
-Demonstrated ability to organize and execute on a variety of assignments and action plans.
-Ability to translate complex concepts into written and visual documentation.
Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or a related field, or previous experience working in the pharmaceutical field