Technical Writer II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Summary:

Support Manufacturing Department by leading technical transfer of products from Formulation and Process Development. Drafts and reviews Master Batch Records and contributes to manufacturing related deviation investigations.

Essential Functions:

• Works with cross function project team to define product parameters and transfer processes from Formulation and Process Development to the cGMP plant.
• Authors Master Batch Records (MBRs) for all processes supported by the site, which are spray drying, secondary drying, oral solid dosage and packaging.
• Manages document approval work flows to enable a successful production schedule.
• Leads and authors Manufacturing related deviations and investigations using root cause analysis tools to determine CAPA.
• Reviews draft documents from other technical writers for cGMP compliance and technical efficiency.
• Maintains and continuously improves library of MBR templates for every unit operation.
• Reviews completed batch records and catalogs observations for future revisions.
• Learns new processes and materials that can improve site expertise and capabilities.
• Drafts & revises Standard Operating Procedures (SOPs) for the Manufacturing department.
• Trains the manufacturing team on SOPs and Batch Records.

Education:

• Bachelor’s degree in STEM and/or 6+ years of relevant experience.
• High school or equivalent experience will be considered for highly qualified candidates.

Experience:

• A minimum of 6 years of cGMP pharmaceutical production or development experience required. Experience in solid oral dosage forms highly preferred. A minimum of 2 years of experience crafting technical documents in a regulated cGMP environment required. Exposure to writing Deviation Investigations and Root Cause Analysis (RCA) techniques & implementation preferred.

Equivalency:

• Equivalent combinations of education, training, and relevant work experience may be considered.

Proficiencies:

• Effective oral and written communication, as well as good collaboration and interpersonal skills
• Extensive knowledge of cGMPs and FDA regulations
• Experience with pharmaceutical equipment, processes, formulations and Good Documentation Practices (GDP)
• Strong math skills
• Ability to manage client expectations in a professional manner
• Knowledge of technical writing standards and protocols
• Proficiency in Microsoft Office software (Word, Excel, PowerPoint).
• Must be extremely detail oriented and organized
• Ability to progress and track multiple projects simultaneously against tight deadlines is important for success.

Physical Requirements:

• Requires ability to move around office and manufacturing areas; perform physical tasks like lifting, carrying, typing, and using equipment.

Disclaimer:

This job description aims to outline the overall content and requirements for performing this job. The description should not be seen as a comprehensive statement of work, responsibilities, or requirements. Additional duties may be assigned by managers and supervisors.

This document does not establish an employment contract. Skills/experiences are briefly stated in job descriptions to align with legal requirements.