Technical Writer
- East Coast
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
One of our major pharmaceutical clients located on the East Coast of the US have been nominated by the government to develop and manufacture COVID 19 Vaccines. As a result, they are involved in a significant facility expansion and are looking to increase the size of their team.
Who are we looking for?
We are looking for an experienced Technical Writer to review, author and approve batch records, specification and other technical documentation. Development and implementation of processes and procedures in support of QA functions (document control, CAPA, product releases). Plan, develop, review, write and approve SOPs for all functional areas as needed.
The ideal candidate will have:
- BA/BS in related field required and/or a minimum 5 - 8 years of proven experience writing standard operating procedures, work instructions, production batch records
- 5 years of experience in biologics, pharmaceutical, or medical device environment
- Candidate must possess in-depth understanding of good documentation practices in a GxP environment
- High degree of customer focus, interdependent partnering, initiative, innovation, team work
- Demonstrated ability to manage complexity and handle/prioritize multiple tasks
- Knowledgeable of FDA regulations, and FDA and ICH guidance documents
- High proficiency in procedure development and a thorough understanding of technical writing
The candidate must have the rights to work in the location stated in the job advert.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’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 Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. 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
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
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Zweli
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