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Documentation Scientist II

Pharmaceutical Product Development (PPD)

Greenville, North Carolina, United States of America

Job Description

Job Description

The primary focus of this job will be the technical writing of production work orders and standard operating procedures. Other tasks will be needed as described in the details below:

Summary:

Technically supports day-to-day operations in the Formulation, Filling, and/or freeze-drying areas of the Steriles plant. Investigates, validates, and may contribute to new scientific methodologies used to control raw materials, production intermediates, and final products on projects of moderate scope. Works on technical/scientific process/product/project activities to execute strategies and technical solutions that meet client needs and expectations. Makes decisions that involve direct application of technical knowledge.

Essential Functions:

· Technical writing of work orders and standard operating procedures

· Implements corrective actions and preventive actions (CAPAs) to eliminate the root causes of deviations.

· Manages projects at the task level under supervision. May manage projects and timelines at the experiment level.

· Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.

· 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.

Education:

Bachelor’s of Science in Chemistry, Biochemistry, Biology, or related physical science preferred.

Experience:

Typically requires 2 years of scientific documentation experience preferred.

Equivalency:

Equivalent education, training, and relevant work experience combinations may be considered (work experience in lieu of a degree).

Competencies:

Good knowledge of scientific methodology, preferably related to pharmaceutical research and development. Good knowledge of Good Manufacturing Practices. Good proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously. Ability to learn new methodologies and to develop technical solutions.

Strong proficiency in Microsoft Office Suite (including Word, Excel, and PowerPoint).

Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.

Excellent critical and logical thinking skills.

Thorough knowledge of Good Manufacturing Practices.

Ability to develop technical solutions.

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.

Job posted: 2024-02-05