Technical Operations Specialist
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- Approximately 75% workload of this position is to lead the cleaning process related needs of the commercial operations unit as assigned by the department. Approximately 25% of the workload responsibility will include equipment qualification related activity and support of various commercial technical operations activities.
- The core work of the Technical Operations Specialist (TOS) will include (1) Cleaning Evaluation Process that includes SOP updates related to cleaning, Documentation design and creation, Review of documents and report writing, (2) Cleaning Validation process that includes creation of master plans, protocols, review of work and report, (3) Conducting annual cleaning re-verification process that includes documentation, review and report, (4) Commercial Cleaning document support (5) Deviation, Discrepancy, CAPAs, Investigations support for both cleaning and process related to commercial manufacturing, (6) Conduct physical testing of samples such as Density, porosity, LOD and PSD, (7) Support Commercial and Process Validation activities as assigned by Department head.
Main tasks and responsibilities will include:
- The TOS will maintain a list of all equipment under Commercial operations and the list will consists of but limited to, surface area, material of construction, surface finish, swab locations, rinse test etc.
- The TOS will be responsible towards designing the cleaning process with focus on uninterrupted yet robust Commercial manufacturing continuity. In close working relationship with the Tech Transfer team, ensures a smooth transfer of product lifecycle from phase III clinical to Commercial launch.
- The TOS will look for opportunity to improve the cleaning process and make it an effective and lean process based on scientific analysis and data driven risk assessments.
- The TOS will support commercial manufacturing, QA, QC and other relevant department staff with training material and exposure to the cleaning process, will lead with the cleaning document design & associated documentation support as needed.
- The TOS will comply & adhere to cGMP & GDP guidelines and regulations as required of this role.
- The TOS will be responsible for ensuring compliance through Compliance Wire, KnowBe4, Veeva and other training medium provided by Quotient, and follow procedures that govern the work performed in this role.
- Create, train and review cleaning documents, execute incident investigations, change controls, support annual product review inputs relating to cleaning validation, validation documents, trends, CAPAs, and identify the risks to the quality of cleanliness and cross contamination.
- Communicates to management on all overview of assigned products.
- Ensures compliance with all aspects of cGMP’s.
- Prepare, approve & execute all necessary documentation, reports, protocols, records, etc. as required.
- Perform cleaning process improvement.
- Review SOPs and performance goals to ensure they reflect a commitment to quality and efficiency.
- NLT 95% compliance at a minimum in all training required to conduct the job.
- Perform other duties as assigned.
- Presentation skill.
- Clear Communication skill (Verbal and written).
The job involves the following:
- Very high concentration of work at times and at regular intervals
- Strict and tight agreed upon deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Organizational skills
- Basic Computer skills
- Ability to take appropriate actions in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team environment.
- Attention to detail
- Attend client meetings and generate orderly meeting timelines
- Bachelor's Degree in Pharmacy, Chemical Engineering, Sciences or its equivalent
- Minimum of 2 years as Cleaning Specialist experience in a cGMP manufacturing environment working with potent OSD finished product compounds.
- Exhibits strong process development skills and must be a quick learner.
- Manages projects to deliver results on time and on budget.
- Proficient in Process Safety concepts and methodology.
- Focused on Meeting Compliance Needs
- High degree of professionalism, ethics, and integrity
- Incumbent must be able to be accountable for own actions and complies with the laws and company policies.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at email@example.com.