GxP Documentation Specialist

Job Responsibilities:

• Utilize technical writing strategies to ensure clarity, conciseness, and completeness of documentation.
• Author and revise technical documentation, including facility and equipment SOPs, batch records, specifications, and training documents.
• Manage change controls to implement new procedures and revisions to documentation and SOPs.
• Participate in process and equipment testing, gaining a comprehensive understanding of systems being documented.
• Complete deviations, CAPAs, change controls, document revisions, and training activities to meet quality system requirements and timelines.
• Collaborate with operations, R&D, and quality representatives to fulfill all project documentation requirements.

Qualifications:

• Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or related field; MS degree is a plus.
• Minimum of 2 years of lab experience, with expertise in HPLC and QA/QC practices.
• Proficiency in technical writing, grammar, and composition.
• Understanding of GMP/cGMP/GLP regulations and quality system requirements.
• Excellent communication skills, both written and verbal, with the ability to collaborate effectively in cross-functional teams.
• Strong time management skills and attention to detail, capable of managing multiple projects in a fast-paced environment.
• Proficiency in Microsoft Word, PowerPoint, and Excel.
• Ability to work independently and collaboratively, demonstrating adaptability and initiative.

Working Conditions:

• Standard office environment with occasional work in laboratory areas.
• Willingness to adhere to safety protocols and wear necessary personal protective equipment.
• Ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
• May require gowning to enter laboratory areas.