Technical Writer
- North America, East Coast
- Contract
- Compliance / Quality Assurance
This is a fantastic opportunity for a Technical Writer to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.
Responsibilities:
- Work together with the Documentation Coordinator, MSAT, Training, Compliance and QA to prepare Site SOPs, Work Instructions, OJT documentation, Forms, Lists and other work process documentation as required for site validation and qualification purposes.
- Discuss, Review, challenge and support definition and documentation.
- Align with IT and key users and document way of working and best practices for Work Instructions.
- Write site specific SOPs.
- Bachelor’s degree in systems engineering or related field.
- Extensive experience in both Drug Product and Drug Substance.
- Experience in the pharmaceutical, biotechnology or medical devices industry in business process delivery including writing process documentation, reviewing process design and process requirements documents, and translating documents into end user procedural guides, using English language.
- Understanding of general supply chain processes and terminology; ideal candidate has warehouse experience and understanding of inventory management processes.
- Independently walk-through process design and requirements documents to understand business processes.
- Identify opportunities to consolidate different test scripts, process, and system transactions into one procedural document.
- Ability to partner and collaborate cross-functionally.
#LI-KS1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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Kristen
I manage this role.