Full time-Permanent (Monday-Friday)
Our client is an industry leader within the cold chain logistics solutions for temperature sensitive materials, this role will have a specialist focus on the Biopharma sector, but they also operate in the Animal Health and IVF fields globally. Founded in the 90’s, they are now a team over 100 employees and are looking to go from a $30M turnover business to a $350M company within the next 5 years
- 2-5 years prior experience in Quality Assurance and/or Regulatory Affairs.
- You will have worked with temperature Controlled Products and Systems, with respective Monitoring Systems
- You will have experience with Biopharma, Life Science, Distribution of Drug Products, or Medical Devices.
- Experience with EDMS, Inventory Control, and monitoring systems, or similar
- Ideally hold membership of a professional Quality related organization (eg ASQ / SQA / RQA)
- Have strong Knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions.
- Must have strong self-motivation, work independently and within a team environment with strong follow up, organization and prioritization skills, and excellent attention to detail.
- Responsible for Quality Management System (QMS) compliance. Establish and adhere to all quality policies, procedures, processes, programs, and practices to ensure continued conformance with appropriate standards and regulations.
- Ensure actions and systems are compliant with (GxP) processes (aligned with the business’s current and future needs), ISO 9001 standards, and other related regulatory standards.
- Assist in the process of investigational analyses pertaining to root-cause evaluation/determination, CAPA implementation, and effectiveness review of said actions taken
- Authors review and approve documents related to Quality Systems such as master batch records, investigation reports, SOPs, and other documents as needed.
- Authors risk assessment as required.
- Develop standard work practices and instructions, procedures, job aids, and business processes.
- May participate in Vendor/ Contractors Qualification activities as assigned.
- Maintain appropriate Document Control records for the department and site.
- Basic Salary Circa: $95,000 – $110,000 (DOE)
- Lucrative Shares/ Stock Options
- Life Insurance
- Holiday Entitlement
For more information about the role or to apply send your CV now to firstname.lastname@example.org or call Blaise Loftus today on +44 (0) 113 243 3499.
You must have the right to work in the USA to be considered for this role.
Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone who would be good for the role, email your nominated candidate’s name and contact details in confidence via email too, and we will ensure you receive $100 (o/e) of vouchers from a high street retailer of your choice once we have successfully placed the person referred by you.
|Job Category||Scientific Supplies|