About the Role

• We are seeking a candidate with an educational background in Science and/or Engineering to join our team in a technical documentation role within the GMP pharma and/or biotechnology industry
• The ideal candidate will have experience working with KNEAT CDOCs and be proficient in editing documentation while adhering to corporate policies and templates.

Responsibilities:

• Develop, review, and update technical content such as SOPs, WIs, risk assessments, protocols, and reports for the manufacturing team.
• Own and provide expertise in Quality System records including deviations, CAPAs, Change Controls, and Quality Risk Management.  Provide technical and clerical support to the manufacturing team in document preparation, data collation, and tracking.
• Collaborate with cross-functional departments to support training documentation for manufacturing staff.
• Participate in continuous process improvement projects and support troubleshooting investigations.
• Ensure timely completion of documentation-related actions 
• Develop protocols for execution in Manufacturing to support change controls, deviations, and troubleshooting investigations.
• Share knowledge with members of the manufacturing team.

Education Qualification:

• Educational background in Science and/or Engineering.

Required Skills:

• Experience in GMP pharma and/or biotechnology industry.
• Proficiency in editing documentation and formatting aligned with corporate policies.
• Exposure to KNEAT CDOCs is highly desired.
• Ability to translate technical information into easily understandable content.