Document Controls Technical Writer (1 of 1)-00000SZG
Description
Janssen Supply Group, LLC is recruiting for a Document Controls Technical Writer. Any J&J based EMEA or US location will be considered for this role.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Document Controls Technical Writer is responsible for developing and instituting technical documentation, as well as reviewing, updating and producing technical documents from information generated by engineering and quality professionals to ensure compliance to internal and external requirements. This position is responsible for originating, editing, revising and obsolescing technical documentation, including but not limited to protocols, test reports, manuals, standard operating procedures, work instructions, and records. The position is also responsible to identify gaps in documentation, and to recommend, initiate and execute corrections to issues. They ensure that document references and connectivity are accurate, and that the document management system remains effectively linked and structured so that it is both compliant and sustainable. The Document Control Technical Writer will contribute to the research, development, and authoring of technical documentation (SOPs, protocols, reports, manuals, etc.) for internal and external use in accordance with JSC document requirements and guidelines. They will also assist with the review, improvement and implementation of a value-added Quality Management System that is complaint to ISO 13485, FDA’s Quality Systems Regulation (21 CFR Part 820) and Combination Products (21 CFR Parts 3 and 4), and ensure that records, files, drawings, procedures, and quality documents comply with regulatory requirements. The Document Control Technical Writer participates as an active team member in cross functional teams, and collaborates with subject matter experts across multiple departments to ensure quality and technical accuracy of documentation. They are responsible for reviewing, improving, and maintaining existing documentation, thereby ensuring adequacy as well as compliance from document initiation to obsolescence. This includes the timely distribution of documents and the removal of obsolete document references within the document management system, as well as to users/departments that are on official distribution.
The Document Control Technical Writer is also responsible for: Supporting the development of documentation as part of change control/change management (design control and technology transfer processes). Creating and submitting Document Change Notice (DCN) packages. Tracking all planned and non-planned deviations, and revising operating procedures accordingly. Creating clear and unambiguous step-by-step work instructions for complex processes. Assisting with CAPA investigations and reporting as well as audit responses and audits/inspections. Assisting with current Good Documentation Practices (cGDP) training. Having the ability to independently compose procedures, work instructions, reports, memoranda and other written materials, perform considerable coordination and follow through, handle/prepare documents of a highly confidential and sensitive nature, and be responsible for document accuracy and adequacy to regulatory requirements. Interacting with various levels of management and maintaining strict confidentiality, with the ability to exercise sound judgment and discretion to independently assess and resolve complex situations/problems, and having the flexibility to respond to shifting priorities with great frequency.
Qualifications
A minimum of a Bachelor Degree is required with preferred disciplines in English, Business, Life Sciences, or a Technical Field; equivalent academic credentials will be considered. A minimum of three (3) years of experience writing technical documents that comply with FDA standards is required. Prior experience working in a document control or change management position is required, preferably in a regulated environment. Strong computer skills, with proficiency in electronic document management systems is required.
Must have excellent verbal and written communication skills, exceptional interpersonal skills, and the ability to work cooperatively and collaboratively with others. The ability to multi-task, work with minimal supervision, and demonstrate resiliency and high productivity in a fast-paced environment is required, operating with a high sense of urgency while maintaining a high degree of professionalism. Strong organizational skills are required. Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment. Experience supporting and working in a matrix organization is preferred. Versed in computing platforms, e.g. MS Office is required.
The position may require up to 10% travel, domestic and international.
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Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:Europe/Middle East/Africa, North America-United States-Pennsylvania-Malvern, North America-United States-New Jersey-Raritan, North America-United States, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, North America-United States-Puerto Rico-Gurabo, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Travel:Yes, 10 % of the Time
Job Function: Quality Assurance
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