Under general supervision, responsible for complex research and analysis of data, documentation, and work flow for work processes, applications and systems; performs technical writing duties related to work process policies and procedures in assigned areas. - Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Writes technical reports for cross-functional review.
- Researches current and proposed rules, regulations, policies and procedures in assigned areas.
- Establishes documentation consistency with department policies, procedures, and SOPs.
- Audits, trends, and provides statistical analysis of technical data using JMP.
- Works closely with multiple departments to coordinate document review, change, and approval activities. This includes document editing, change control, and review/approval cycling.
- Develops, writes, updates, and reviews SOPs, test methods, and worksheets.
- Supports filing activities for regulatory submissions as needed.
- Works in compliance with existing Company policies and procedures including safety rules and regulations.
- Reviews and provides product impact assessment related to new and proposed industry regulations and standards (e.q., USP, Ph. Eur., ICH, etc.).
- Performs related duties as assigned.
Three (3) to five (5) years general laboratory experience including three (3) years of developing and writing work process procedures.Knowledge of:
•Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory compliance requirements.
- Pharmaceutical principles, practices and applications.
- Mathematical and statistical principles and computations.
- Conducting review of technical methods, tests and applications.
- Documentation principles and practices.
- Business English usage, spelling, grammar and punctuation.
- Related business, scientific and personal computer hardware and software applications.
- Implementing goals, objectives and practices for effective, efficient and cost effective
management of allocated resources.
- Researching, reading, interpreting and writing technical documentation, merging
company and compliance regulations into Standard Operating Procedures.
- Reading, understanding, and complying with current Company policies and procedures
including safety rules and regulations.
- Analyzing complex problems, identifying solutions, and implementing recommendations
for problem resolution.
- Developing management level presentations.
- Communicating clearly and concisely, both orally and in writing.
- Operating personal computer and area software.
- Handing multiple projects, duties and assignments.
- Establishing and maintaining cooperative working relationships with others.
Bachelor of Science Degree from an accredited college or university.*LI-WK1