Technical Writer
GlaxoSmithKline Consumer Healthcare, L.P.
Site Name: USA – Montana – Hamilton
Posted Date: Oct 16 2024
The purpose of Technical Writer role is to:
- Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing.
- Serve as liaison between manufacturing groups, as well as between manufacturing and support departments, to ensure accurate, compliant and streamlined controlled documents.
- Drive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documents.
- Champion standardization of documents across groups within manufacturing (e.g., content, structure, format, etc.)
- Serve as a change coordinator for projects in the manufacturing departments.
- Partner with learning and development as well as Manufacturing groups to ensure documents support accurate representation of operations and provide a foundation for education and competency
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Environmental Health & Safety:
- Promote a highly safety conscious culture and EHS focused workforce. Perform all job responsibilities in compliance with applicable regulations, current operating procedures, and industry practice.
Quality & Compliance:
- Support integration of overarching Manufacturing systems and procedures to achieve inspection readiness at all times. Ensure all activities are executed following quality and regulatory standards. Support implementation and monitoring of quality systems to achieve inspection readiness at all times. Promote a quality mindset and quality excellence approach to all activities. Adhere to all GSK Quality Management System (QMS) policies and procedures as applicable.
- Format and manage documents using appropriate guidelines and established document templates
- Evaluate LSOP change requests to determine scope of change, and ensure accurate information in revision history (associated CAPAs, Change Controls, Impact Assessments, etc.)
- Where appropriate, manage CAPA tasks related to LSOP revisions
- Determine when LSOP duplications exist and manage resolution and consolidation of affected documents
Continuous Improvement:
- Support Lean/Six Sigma program to drive and embed a culture of continuous improvement by the use of operational excellence methodologies to realize ever-increasing levels of value in the usability and practicality of documents
- Partner with local Learning and Development team to drive the revision and creation of SOPs and GMP documents that enable effective training, retention of information and competency.
- Incorporate revisions and ensure consistent terminology and language for presentation of information.
- Partner with key stakeholders and drive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documents.
Accountability:
- Partner with LSOP Process Owners, to obtain accurate content for inclusion in documents, utilizing shop floor Gembas and process walk-downs, to drive inclusion of effective and accurate content in documents, and communicate significant LSOP changes in procedures to process owners
- Partner with Doc Adnims to ensure documents are submitted for upload into eSOP in an accurate, timely manner.
- Monitor document cycle time and escalate overdue tasks as required.
Change Management:
- Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves. Positively influence others ability to adapt to change.
Why you?Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelors Degree in any Discipline
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Bachelors Degree in Technical Writing degree or specialized training in technical writing
- Knowledge of cGMP, FDA and other regulatory requirements and quality systems
- Working knowledge of SAP with demonstrated ability to learn other facets of SAP (i.e. eSOP, and change control)
- Proficient use of MS Office Suite, Visio, digital imaging
- Ability to prioritize and flexibility to adapt to changing business schedules and deadlines
- Ability to coordinate projects involving multiple documents and clients
- Good communication, organizational and team skills
- Public speaking/presentation
- Ability to take initiative and work proactively with creative problem-solving skills
- Demonstrated experience driving change and delivering results with a strong commitment to individual accountability for tasks
- Strong interpersonal communication skills and ability to thrive in a dynamic team environment
- Capable of working without direct supervision
- Committed team player prepared to work in and embrace a team-based culture
#EarlyCareers
#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
- Date Posted: November 18, 2024
- Location: Hamilton, MT
