Senior Technical Writer
Somerset, NJ
Contract
Summary:
The Technical Writer will ensure all documentation activities are carried out in compliance with regulatory requirements, Good Manufacturing Practices (cGMP), and standard operations procedures.
Job description:
· Creation and revision of batch records and SAP recipes for manufacturing and packaging of an array of products including tablets, capsules, liquids, suspensions, and powders.
· Creation and revision of batch records and Standard Operating Procedures (SOP’s)
· Provide recommendations on packaging materials selection, suppliers.
· Calculate theoretical weights for sales from the SKU to the pallet level Manage and control manufacturing documents during multiple revisions, ensuring accuracy of the original documents and the integrated changes.
· Prepare and ensure readiness for packaging of new product launches.
· Implement a system for the palletization of pallets on the packaging line including CAPE PAK diagrams in batch records.
· Coordinate studies for child resistance and develop new packaging solutions to achieve the required security.
· Creation of exhibit batch records for initiation of stability for the introduction of new packaging materials.
· Selection, confirmation, and implementation of packaging materials (bottles, caps, labels, shippers, cartons, blistering materials) for new packs as well as comparisons with existing materials equivalency.
· Draft and execute protocols to test new packaging materials on existing lines and initiate stability
· Create and execute change controls.
· Work with third parties to coordinate packaging activities including review and approval of records.
· Draft and execute protocols for packaging line trials or product rework.
· Work with several departments including QA/QC, Production, Marketing, Sales, Regulatory, Purchasing, and Planning daily in a GXP environment.
· Collaborate with SMEs to capture best practices and accurate documentation.
· Organize material and complete writing assignments according to set standards regarding order, clarity, conciseness, style, terminology and SOP’s.
· Maintain records and files of work and revisions.
· Recommends changes to the process to enhance efficiencies and improve current processes.
· Become familiar with production processes and methods by building productive relationships with production, engineering, validation, and development personnel.
· Observe production, developmental, and experimental activities to understand detailed operating procedures and methods to create effective manufacturing documents.
· Train or assist in the training of new hires.
· Other duties as assigned.
Qualifications:
· Bachelor or Master's Degree in a scientific discipline.
· 8+ years' experience in benchwork or technical writing for a Liquid and/or Oral Solids Manufacturing.
· Must have excellent grammatical skills and effective oral and written communication skills.
· Adaptable to changes in work duties, responsibilities, and requirements and can manage the workload.
· Strong interpersonal skills; capability to work as part of a team with formulation scientists and other departments.
· Detail-oriented, thorough, and methodical, and excellent organizational and planning skills with the ability to manage and prioritize multiple tasks while still meeting deadlines. Possesses good editorial/proofreading skills and understands and performs well in the process of writing (outlining, drafting, revising, and reviewing).
· Excellent organizational skills.
· Able to perform numerous simple and complex tasks without losing sight of overall objectives.
· A strong understanding of Word and Excel is critica.
· The position requires proficient personal computer skills including electronic mail; record keeping, routine database activity, word processing, spreadsheet, and graphics.
ANY GRADUATE