Documentation Specialist (Manufacturing Intern)
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.
As a Documentation Specialist (Manufacturing Intern), you will be responsible for processing and archiving documents according to regulatory standards.
Main tasks and responsibilities will include:
- Maintaining a document index to track the status and location of paper documents and records.
- Managing manufacturing and laboratory records throughout their lifecycle.This includes generating, issuing, archiving and retrieving the records.
- Controlling access to archived records.
- Providing training to personnel on the documentation process.
- Ensuring compliance of the GMP documentation process.
- Working with Project Managers to meet the established timelines for product realization.
- Communicating with Clients regarding document processing statuses.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, DOT, OSHA and DEA.Comply with all company and site policies and procedures.
- Remain current in profession and industry trends.
- Make a positive contribution as demonstrated by:
- Make suggestions for improvement. Implement changes as needed.
- Work as part of a team
- Learn new skills, procedures and processes.
- Be available for other duties as required.
- Currently enrolled at an accredited university with degree focus in engineering, scientific, or related major OR Bachelor’s degree or equivalent coupled with 0 to 3 years of experience in pharmaceutical document control.
- Experience with electronic documentation management systems is a plus.
- The candidate must possess good organizational skills to organize the information, data, documents and reports. Must be able to multitask and work on various documents during a given period of time.
- Successfully completes regulatory and job training requirements.
- Proficient in Word, Excel and Outlook at a minimum.
- Ability to work with others in a team environment.
- Ability to work with little supervision.
- Attention to details.
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.