QC Lead Analyst

SGS; Rathdrum; On-site; EUR 60,000 - 90,000; Full time

Job summary

SGS Ireland is seeking an experienced QC Lead Analyst to join our Scientific In-sourcing team on a site-based role. You will lead a client-based team of QC analysts, manage training and development, and ensure two-way communication between SGS and the client.

In this GMP environment you will test pharmaceutical substances using HPLC, GC and UV, oversee method optimisation, review data, and drive improvements in quality, safety and throughput while maintaining high housekeeping and compliance

Qualifications

• Bachelor of Science in Chemistry or equivalent NFQ Level 7.
• More than five years' experience in analytical testing (HPLC, GC, UV, wet chemistry).
• Familiar with GMP and analytical technologies.
• Proven track record in leading teams.

Responsibilities

• Lead a client-based team of QC analysts and oversee training and development.
• Ensure testing is completed on time, right first time, and to specification.
• Review data and ensure GMP documentation is accurate.
• Maintain high housekeeping and instrument maintenance.

Skills

Leadership

QC Testing

GMP

HPLC

Education

BSc Chemistry or equivalent

Tools

LIMS

SOPs

Job description

SGS are the world’s leading testing, inspection and certification company SGS Group. We deliver solutions to a wide range of industry sectors in Ireland. Enjoy a truly rewarding career in a global, multicultural organisation with a proud heritage that has been making the world a better, safer place for over 140 years.

Our client services include providing SGS QC analysts and technical support staff on-site to fulfill staffing requirements (Scientific In-sourcing), all under the supervision and guidance of ISL technical and operational teams. Like all SGS personnel, they are committed to upholding stringent technical and GMP standards, ensuring the safety of medications for the multitude of patients relying on the products we test.

Due to growth, we have an exciting opportunity for an experienced QC Lead Analyst to join our growing Scientific In-sourcing team.

Job Description

Lead a client-based team of QC analysts to meet client requirements. People management responsibility, including oversight of training and development and establishing empowerment and accountability through effective leadership and coaching. Ensure two-way communication between SGS and client.

Role will also involve acting as an analyst where required. Testing of pharmaceutical substances e.g. raw materials and drug substances in a GMP environment in accordance with clients’ procedures and quality system. Demonstrating own knowledge and expertise in complex testing, complex decision making and leading troubleshooting. Optimisation of methods and equipment. Leads improvements in quality, safety, sustainability and throughput. Operates with little supervision.

Lead Analyst:

• Act as SGS daily point of contact with client, ensuring strong communication with the client and SGS
• Oversee execution of the operational plan to ensure optimal productivity and reliable execution
• Lead team to ensure that all testing is completed on time, right first time and to the required specification
• Optimise and report key performance indicators- quality, safety, productivity, on time delivery
• Ensure provision of excellent customer service, identifying and implementing continuous improvements in efficiency and service
• Problem solving and resolution of queries, linking with support resources in SGS and in the client
• Ensure adequate cross training to meet client needs and cover within the team
• Review and verify data generated
• Maintain laboratory facilities and equipment used by the team- ensure high housekeeping standards
• Ensure lab supplies are available as required
• Review and approve GMP documents such as SOPs, temperature monitoring profiles, calibration records
• Be qualified in and administer basic First Aid
• Support in preparation and execution of audits

Key accountabilities as an analyst:

• Receive training from SGS and client and getqualifiedin relevant analytical techniques. Maintain own training 100% current. Train other analysts where appropriately qualified
• Carry out testingin accordance with the valid testing procedures and regulatory requirements
• Ensure that laboratory equipment iswellmaintained,and calibrations are carried out at the designated frequencies
• Manageinventoryand status of materials required for analysis
• When qualified to do so,verify and review resultsgenerated by other analysts for compliance with requirements
• Ensure correct data entry to LIMS
• Assessment of testing results generated in the laboratory and close out of batch analysis
• Ensure that alltarget dates are met. Update visibility tools and communicate status of testing at meetings
• Maintain laboratories to a high housekeeping standard
• Ensure high standard of lab records, with work completedRight First Timeand on time
• Write and maintain necessary documentation (SOPs, methods report etc)
• Work as part of the team ensuringcustomer expectations aremetand exceeded. Support achievement of client and SGS Key Performance Indicators, such as around investigations, training, productivity and on-time testing
• Notify appropriate contact and document results and investigations for any atypical or aberrant results
• Lead Laboratory investigations and deviations if required
• Maintenance of a safe working environment, in a state of audit readiness
• Identification and implementation of safety, environmental, quality and serviceimprovements
• Work with their leader to ensure self-development and progression

Qualifications

• Bachelor of Science Graduate in Chemistry or equivalent education (NFQ Level 7)
• Demonstrated competency equivalent to more than five years’ experience in analytical testing (HPLC, GC, UV, wet chemistry, dissolution, etc)
• Familiarity with current Good Manufacturing Practices and sound knowledge of analytical technologies
• Proven track record in demonstrating leadership and influence

Additional Information

Core Competencies

• Develop Self & Others
• Translates Strategy into Actions
• Delivers Superior Results
• Influences Internally & Externally
• Builds High Performance Teams
• Strategic Thinking
• Leads in Uncertainty

Candidates must be immediately eligible to work in Ireland, this is a site based role.

We are an equal opportunity employer and value diversity at our company.