Associate QC Specialist

at  ORION

Job description

Experience/Education Required:

• 2-4 years of experience in a cGMP laboratory environments.
• Knowledge of or previous experience in New Material Introduction process.
• Proficiency in Microsoft Office and job-related computer applications required.
• Good communication, interpersonal skills and ability to work across teams.
• Demonstrated ability to drive the completion of tasks.
• Demonstrated ability to solve problems/perform investigations.
• Method validation and method transfer experience would be advantage.
• Bachelor’s degree or higher preferred; ideally in Chemistry, analytical chemistry or a related Science discipline or relevant experience

The successful candidate will support all aspects of New Material Introduction process and associated supplier changes ensuring effective interaction with other departments/global teams on matters related to new material introduction and associated qualification as well as support selection and management of external testing Laboratories ensuring all outsourced methods are validated and suitable for the product/material required

Functions:

• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
• Facilitate and drive effective communication to ensure success through representation of QC team on tier meetings.
• Support all aspects of New Material Introduction process ensuring effective interaction with other departments/global teams/ external contract testing labs on matters related to new material introduction, supplier changes and associated qualification.
• Participate and support Internal/External Investigations.
• Coordinate the creation/ update to Quality standards for raw materials and components at Carlow. Complete impact assessments for change controls related to Carlow processes
• Coordinate any efficiency/ increased Lab capability projects as detailed by Quality Control Manager.
• Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Coordination, ownership, and author as required for Annual Product Review
• Participate in Quality Risk Management.

Experience/Education Required:

• 2-4 years of experience in a cGMP laboratory environments.
• Knowledge of or previous experience in New Material Introduction process.
• Proficiency in Microsoft Office and job-related computer applications required.
• Good communication, interpersonal skills and ability to work across teams.
• Demonstrated ability to drive the completion of tasks.
• Demonstrated ability to solve problems/perform investigations.
• Method validation and method transfer experience would be advantage.
• Bachelor’s degree or higher preferred; ideally in Chemistry, analytical chemistry or a related Science discipline or relevant experience.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment