- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Come join our team and make a meaningful impact on patients’ lives.
- We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
- Reporting to the QC Team Leader, the primary role of the QC Analyst is to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards. Ensuring our products are safe for patient use and fit for purpose.
- The team is divided into 3 sub-teams QC Analytical; QC Microbiology and QC In-Process.
- The role could potentially lie within any of these sub-teams depending on experience and requirement. Shift work may be required.
SKILLS/ KNOWLEDGE/ BEHAVIOURS
The role potentially will cover both Analytical and Microbiological testing including but not limited to the following:
- Microbiological testing performed by the lab incl: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & BIs
- Anaytical testing performed by the lab incl: HPLC, SDS, FTIR, UV, plate based assays; capillary electrophoresis
- Testing of finished product, raw materials, packaging and stability
- Perform primary review of QC raw data and trend results
- Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate and troubleshoot analytical test methods
- Draft QC SOPs
- Act as technical resource (SME)and train other analysts in areas of expertise
- Evaluate results against defined acceptance criteria
- Conduct and document laboratory investigations to completion
- Maintain the laboratory in an inspection-ready state
- Interact directly with regulatory agency inspectors during audits
- Interface with other company departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
- Excellent communication skills both written and verbal
- Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
- Self-motivated and ability to work under pressure
- Team Leadership – active participation team development and continuous improvement including standard work and 5S
- Demonstrated adaptability and flexibility to support a growing organisation.
B.S. in a scientific discipline with 3+ years of relevant laboratory experience.
- Ability to work independently and meeting established timelines.
- Comfort with coordinating the activities with other staff members.
- Comfort with working in a team environment
- Knowledge of cGMPs.
- Reports to Quality Control Manager/Team Leader.
- Interacts with several departments, including but not limited to Manufacturing, Quality Assurance, Maintenance, Engineering, and Manufacturing Sciences.
- This description is not intended to be all-inclusive or a limitation of the duties of the position.
- It is intended to describe the general nature of the job that may include other duties as assumed or assigned.