Job Description/Major Responsibilities:|
Designs, creates, revises and maintains technical documentation. Utilize SME's, design specifications, users, system manuals etc. for guidance.
Autonomy and Complexity:
- Interviews subject matter experts and the users of the processes as well as conduct research and have the ability to gather information to produce a clear concise document to the target audience
- Form a clear understanding of the purpose of the document that needs to be created.
- Gather information from existing process flow documents, equipment manuals and from subject matter experts.
- Draft SOPs and explain in simple language scientific and technical ideas that are difficult for the average reader to understand.
- Write the SOP in a concise, step-by-step, easy to read and follow format.
- Edit, proofread, perform formatting of technical documents for business and consumers.
- The information presented in an SOP should be unambiguous and not complicated.
- Information should be conveyed clearly and explicitly to remove any doubt as to what is required.
- Determine if a Supplement/Form or Work Instruction document is needed. WI contains much more detail than an SOP and is only created if very detailed instructions are needed.
- Afterward, develop work Instructions that contains detailed instructions that specify exactly what steps to follow in order to complete an activity.
- Communicate activities and results to the site leadership.
- Work closely with External Manufacturing Quality to develop and report appropriate metrics.
- Demonstrate professional leadership with the proven ability to build business relationships
- Strong interpersonal and communication skills are also required as the individual must be able to work both with a team of SME & future user and other authors to move process forward to completion. Demonstrated ability to facilitate groups.
- Proactively identifies issues and seeks resolution within the team.
- Responsible to provide feedback to upper management.
- Bachelor's degree in either a scientific, engineering field or in English is required; an advanced degree is preferred.
Comprehensive understanding of the technical writing process.
- Proven strong writing and editing skills.
- A minimum of 5 years of demonstrated experience in writing SOPs, Supplements/Forms and WIs, in the Pharmaceutical Industry.
- Proven track record of strong communication skills demonstrated by successfully communicating with large groups are required.
- Ability to communicate effectively to all levels of the organization
- Ability to effectively present information and respond to questions or complex inquiries from groups of employees, managers and internal customers
- Demonstrated planning and tracking skills
- Demonstrated organizational skills, capable of managing multiple tasks
- Must have demonstrated strong cross-functional collaboration and teaming in a global environment.
- Proven influence, leadership and facilitation skills.
- Able to manage time with respect to priorities;
- High level of proficiency in Microsoft Office (Visio, Access, Word, Excel, Adobe Acrobat, etc) is required.
- Ability to communicate well with all levels of staff and organize inter-departmental meetings is required.
- The ability to pay attention to details and accuracy while being flexible, able to adapt to changing priorities
<10% travel is anticipated for this role.
Tunnell Consulting - 9 months ago
Tunnell Consulting has operated as an ESOP company (Employee Stock Ownership Plan) since 1988. This means each employee is also a company ow...