Senior Technical Writer

About the job

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.