Technical Writer

Job Summary:

This position formats, writes and revises company documents.  This position will facilitate drafts and revisions of SOPs and additional company documents. As a Technical Writer, this position will work with several departments and assist with the necessary documentation for system transitions and onsite demand.

Job Responsibilities:

• Writes or revises department documents, including but not limited to Batch Records, Work Plans, Addendums, Forms, Checklists, SOPs, Knowledge Checks, Answer Keys, and Qualification Checks.
• Assists all departments with documentation.
• Manages multiple assignments simultaneously, while working independently and with others.
• Creates documents in a timely manner without errors.
• Select and include appropriate photographs, drawings and diagrams to improve document usefulness.
• Arranges for typing, change control, copying, training and distribution of documents.
• Ensures documentations meet triennial review dates.
• Tracks and communicates the status of document changes.
• Communicates with Department Trainer/Coordinator to ensure department training requirements are met.
• Assists training team with training documentation entries as during high-peak entry periods (e.g. Annual GMP training).
• Works as a member of a team to achieve all outcomes;

• Performs all work in support of our Values: Innovate, Evolve & Excel and

• All other relevant duties as assigned.

Qualifications

• Education

• College degree (B.S or B.A.)

• Knowledge, Skills and Abilities

• Knowledge of current Good Manufacturing Practices(cGMP)
• Knowedge of Pharmaceutical principles, practices and applications.
• Proficient in mathematical and statistical principles and computation.
• Knowledge of documentation practices and principles
• Proficient in business English usage, spelling, grammar and punctuation
• Ability to read, write and speak English effectively and communicate clearly and concisely with all company employees.
• Computer literacy with Microsoft Office programs required and exposure to SAP, QMS and other systems preferred.
• Skills in researching, reading, interpreting and writing technical documentation, merging company and compliance regulations into Standard Operating Procedures.
• Demonstrated ability to handle multiple priorities in a fast paced environment.
• Ability to work within a team environment (as part of a team) as demonstrated through previous work experience.
• Proven experience in systematic problem solving

• Experience

• 1-3 years of direct job related experience

Salary : $27 - $30