MSAT Documentation Scientist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

The Manufacturing Sciences & Technology (MSAT) Documentation Scientist is responsible for strengthening operational excellence by developing and maintaining GMP documentation, coordinating training programs, and driving continuous improvement initiatives. This role partners with cross-functional teams to implement documentation and training strategies, ensure regulatory compliance, support audits and inspections, and enhance workforce readiness through effective knowledge management and process improvement in a regulated pharmaceutical manufacturing environment.

How will you make an impact?

• Technically supports day-to-day Operations and Manufacturing Sciences and Technology in the Manufacturing, Filling, Freeze Drying, and/or Packaging areas of the Steriles business unit.
• May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development.
• Works on technical/scientific process/product/project activities to execute strategies and technical solutions that meet client needs and expectations.
• Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with independent judgment.
• Makes decisions that require developing new options to solve complex problems.

What will you do?

• Author and improve procedures including SOPs, Batch Records, Protocols, training documents, etc. Author Change Controls, in electronic Quality Management System and Document Management System.
• Leads cross functional investigation teams in CAPA closure.
• Present recommendations internally.
• Leads assignments, including managing project timelines and deliverables.
• Liaises with internal Quality, Operations, Engineering, Validation, and other functional areas to meet team objectives.
• Guides and advises documentation and training strategies during implementation of new methodologies and processes.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
• Maintains the necessary compliance status required by company and facility standards.

How will you get here?

Qualifications

• Bachelor of Science in any Science or STEM degree preferred. Associate degree is preferred. Other Education and time in industry can be considered.
• 0-2 years of progressive scientific experience and/or coursework
• 2-4 years of scientific experience (preferred), preferably in the pharmaceutical industry. Education and time in the industry can be considered.
• Experience with technical writing is a plus
• Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

• Thorough knowledge of Good Manufacturing Practices.
• Strong proficiency in Microsoft Office Suite (including Word, Excel, and PowerPoint).
• Excellent critical and logical thinking skills.
• Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.
• Ability to work on multiple projects simultaneously.
• Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
• Ability to keep current with scientific literature and industry trends relating to process technologies.
• Ability to develop technical solutions.
• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.