Documentation Associate

New Brunswick, NJ

Posted: 06/24/2024 Industry: Scientific Job Number: 24-00275

Job Description

Documentation Associate

Documentation Associate support the site(s) documentation system and ancillary support systems. This role will contribute to MSTG's efforts that aim to support development and validation program. The Documentation Associate will work on both daily tasks and project tasks.
  • Responsible for creation and revision of controlled documents related to the Quality System utilizing technical writing skills to ensure proper formatting, numbering and organization of all related documents (e.G. SOP, Batch record, study protocol, reports, etc.) in GMP environment.
  • Responsible for the revision of documents for accurate grammar, spelling, punctuation, presentation, etc., and to improve clarity, syntax, logic, flow, organization, etc
  • Coordinate document / record requests between departments
  • Provides guidance and training to staff and user departments in accurate use of the document / record management systems
  • Review executed documents for accuracy and completeness.
  • Follows internal Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and complying with legal regulations.

Experience needed:
Minimum Bachelor's degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university
Knowledge of pharmaceutical manufacturing and related documents
Preference will be given to candidates with experience in pharmaceutical manufacturing
Proficient in MS Office (Word, Excel, Projects, PowerPoint).
Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment
Ability to work effectively both independently and as part of a team
Capable of handling and participating in compliance and regulatory audits at the local and federal levels
Ability to understand and analyze complex data sets
Organizational and recordkeeping skills.
Strong analytical thinking, problem solving skills and decision making skills.
Strong communication (verbal and written) skills.
  • 6 months to 1 year of experience in pharmaceutical manufacturing or GMP environment.

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