Document Review Specialist
- United States
- Contract
- CAPEX Projects
Our client is a large CDMO that specializes in cell culture and gene therapy. We are currently looking for Document Review Specialists with hands-on background in biotech and greenfield projects. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Main Responsibilities;
- Ability to read and understand CQV and site quality procedures and align with FDB Large Scale Biologics operating principles and regulatory requirements.
- Ability to work with an electronic validation system such as KNEAT or similar systems.
- Conduct GDP reviews of test protocols pre and post execution to facilitate a timely review and approval process with Quality.
- Utilize and own GDP checklist to track errors found in protocols and other documents. Update checklist as needed to ensure comprehensive list of potential GDP errors.
- Conduct general documentation reviews of specifications, design documents, procedures, work instructions, etc. to ensure GDP requirements are met and standard formatting is maintained.
- Liaise with CQV Leads, CQV Engineers and other departments to resolve GDP errors in protocols and documents.
- Drive timely protocol closure for each phase of CQV.
- Track and report weekly protocol closures.
- Train CQV teams on GDP standards.
Requirements;
- 3-5 years in a similar documentation review and/or Quality Assurance role for cGMP Documentation.
- Prior experience with cGMP or in other highly regulated industries such as on Large Scale Projects and/or GMP operational facility.
- Experience with liaising with other departments and engineers/QA, ensuring streamlined implementation of documentation review process or similar type process.
- Willingness to step in a proactive manner for driving progress
- Strong communication skills and ability to escalate issues as needed.
- BA/BS in a related field and 3+ years’ experience successfully executing complex projects in a Pharma/cGMP environment.
- Emphasis for this hire is on attitude (Positive Can-Do attitude) and strong collaboration.
- Acts with detail-driven ownership and follow through.
- Minimum of 3 years of cGMP documentation experience.
- Kneat experience would be a bonus
- Experience with complex projects and working in or around operating facilities.
- Ability to keep work pace and meet deadlines. Good organizing and planning skills.
- Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
If this role is of interest to you, please apply now!
#LI-MC1
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
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
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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