Pharmaceutical Documentation Specialist
1 month ago
Pharmaceutical Documentation Specialist
Location: Tamarac, FL
Type: On-site, Contract
DESCRIPTION:
Are you a detail-oriented Pharmaceutical Documentation Specialist with a passion for creating and revising company documents? We are seeking a talented individual to join our team. In this role, you'll be instrumental in formatting, writing, and enhancing critical documents for various departments, focusing on Standard Operating Procedures (SOPs) and other essential company materials. You will collaborate with multiple teams to support documentation needs, particularly for system transitions and on-site requirements.
RESPONSIBILITIES AND DUTIES:
- Write and revise departmental documents, such as Batch Records, Work Plans, Addendums, Forms, Checklists, SOPs, Knowledge Checks, Answer Keys, and Qualification Checks.
- Provide assistance to all departments for their documentation requirements.
- Manage multiple assignments concurrently, working both independently and as part of a team.
- Produce error-free documents within specified timeframes.
- Select and incorporate relevant photographs, drawings, and diagrams to enhance document usability.
- Coordinate tasks related to typing, change control, copying, training, and document distribution.
- Ensure that documentation meets triennial review dates.
- Track and communicate the status of document changes.
- Collaborate with the Department Trainer/Coordinator to ensure department training requirements are met.
- Support the training team with training documentation entries, particularly during high-peak entry periods, such as Annual GMP training.
- Work harmoniously within a team to achieve collective goals.
- Perform any other relevant duties as assigned.
REQUIREMENTS:
- 1-3 years of direct job-related experience.
- A college degree (B.S. or B.A.).
- Proficiency in current Good Manufacturing Practices (cGMP).
- Understanding of pharmaceutical principles, practices, and applications.
- Strong mathematical and statistical skills.
- Familiarity with documentation practices and principles.
- Excellent command of business English, including usage, spelling, grammar, and punctuation.
- Effective written and spoken English communication skills for clear interaction with all company employees.
- Computer literacy with proficiency in Microsoft Office programs; exposure to SAP, QMS, and other systems is a plus.
- Skills in researching, reading, interpreting, and writing technical documentation, effectively merging company and compliance regulations into Standard Operating Procedures.
- Demonstrated ability to manage multiple priorities in a fast-paced environment.
- Proven experience in systematic problem solving.
- Capability to work effectively within a team environment, as demonstrated through previous work experience.
At ttg, “We believe in making a difference One Person at a Time.
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