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.
The role potentially will cover both Analytical and Microbiological testing including but not limited to the following:
- Microbiological testing performed by the lab include: 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 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
- Successful track record in achieving goals as part of a team within a growing, dynamic environment
- Demonstrated adaptability and flexibility to support a growing organisation
- BSc. in a scientific discipline with 3+ years of relevant laboratory experience.
- Comfort with coordinating the activities with other staff members.
- Comfort with working in a team environment
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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