Technical Writer III

Organization
Actavis, Inc.
Job Location
Salt Lake City, UT
Job Description

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.

Requirements:
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.

Skill In:
- 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

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