Description
Position Summary:- Incumbent will assist in the creation, review and revision of documents (SOPs, forms, jobs aids, training material, etc.) and other manufacturing department documents.
- Incumbent will work with co-workers and supervisors to understand the objective of each document to ensure that all documents contain the required content.
- Incumbent will interpret information and organize it properly for accuracy, readability and format, while ensuring the proper grammar and spelling is used in all documents.
- Perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures.
- Edit and format incoming requests for new or revised documents (SOPs, forms, jobs aids, training material, etc.) and assist in tracking each revision through the approval workflow.
- Provide assistance with development of new and revised documents including suggestions for suitable terminology, content, and format while ensuring that site policies comply with Corporate guidelines.
- Participate in the bi-annual review of Standard Operating Procedures, forms and other related documents.
- Complete commitments as assigned to facilitate Corrective Actions/Preventative Actions.
- Participate in the bi-annual review of Standard Operating Procedures, forms and other related documents.
- Complete commitments as assigned to facilitate Corrective Actions/Preventative Actions.
- Assist in maintaining control of documentation to include accurate document history and change revision documentation.
Technical Skills:
- Able to edit documents quickly and efficiently to incorporate required revisions
- Develops and applies standardized document formats where applicable.
- Able to learn and navigate document control and e-systems to facilitate document routing and approval
- Able to effectively proofread documents prepared by self and others for content and others to ensure accuracy.
- Able to write clearly and concisely with strong English background with excellent grammar, good writing skills and knowledge of sentence structure
- Effective active listening skills.
- Able to translate verbal guidance into precise operating instructions
- Adheres to and applies standard document formats while maintaining technical content of new and revised documents
- Demonstrates an ability to adapt to shifting priorities, change, stress and to find appropriate balance between needs of the organization, others and self. Incorporates insights of other people into ongoing work.
- Able to learn and understand pharmaceutical processes in order to design related SOPs.
- Understanding of cGMP and Safety regulations
- Strong organizational and communication skills
- Team based collaborative problem solving
- Strong understanding of cGMPs
- Good Manufacturing Practices (GMP)
- Standard Operating Procedures (SOP's)