Technical Services Associate

NCBiotech; Wilmington (NC); On-site; USD 55,000 - 85,000; Full time

Job summary

NCBiotech is seeking a manufacturing associate to support GMP Synthesis, Manufacturing and Formulation Services. The role focuses on batch records, cleaning documentation, and process validation in a fast-growing environment.

You will collaborate with manufacturing, QA, validations, metrology and business development to keep facilities compliant, transfer processes, and deliver timely results while maintaining client confidentiality.

Qualifications

• Associate degree or higher in a scientific or engineering discipline.
• At least 3 years of experience or equivalent education/experience.

Responsibilities

• Initiate or revise batch records for products and processes.
• Create documents for and execute cleanability studies.
• Create and maintain cleaning documentation for products and processes.
• Create documents for and work with manufacturing and formulations team to execute DOE studies.
• Create technical transfer documentation for products and processes.
• Develop Standard Operating Procedures and training materials for manufacturing processes, as applicable.
• Create documents for and execute process and product validations.
• Perform batch data trending and write reports, change requests, and deviations (as required).
• Assist in the production and packaging of R&D and GMP products, as required.
• Work with the manufacturing, validations and metrology teams to maintain equipment, utilities and facility in a ready state of compliance including keeping them clean, calibrated and qualified.
• Monitor viewLinc (environmental monitoring system) and respond to excursions as needed.
• Work with clients to transfer in/out products and processes.
• Assist in the performance and trending of environmental monitoring of the GMP Synthesis, Manufacturing and Formulation Services areas.
• Maintain strict client confidentiality.
• Work with manufacturing and formulation management to investigate aberrant data.
• Work with quality group to ensure compliance for all GMP work.
• Work with Business Development and management to develop timelines for work activities.
• Communicate daily with manufacturing and formulation management about work scheduling and project progress/results.

Education

Associate degree or higher in a scientific or engineering discipline

Job description

Minimum Requirements

This position requires an Associate degree or higher in a scientific or engineering disciplines with at least 3 years of experience or an equivalent combination of education and experience.

Responsibilities

Initiate new or revise existing batch records for products and processes. Create documents for and execute cleanability studies. Create and maintain cleaning documentation for products and processes. Create documents for and work with manufacturing and formulations team to execute design of experiment studies. Create technical transfer documentation for products and processes. Develop Standard Operating Procedures and training materials for manufacturing processes, as applicable. Create documents for and execute process and product validations. Perform batch data trending and write reports, change requests, and deviations (as required). Assist in the production and packaging of R&D and GMP products, as required. Work with the manufacturing, validations and metrology teams to maintain equipment, utilities and facility in a ready state of compliance including keeping them clean, calibrated and qualified. Monitor viewLinc (environmental monitoring system) and respond to excursions as needed. Work with clients to transfer in/out products and processes. Assist in the performance and trending of environmental monitoring of the GMP Synthesis, Manufacturing and Formulation Services areas. Maintain strict client confidentiality. Work with manufacturing and formulation management to investigate aberrant data. Work with quality group to ensure compliance for all GMP work. Work with Business Development and management to develop timelines for work activities. Communicate daily with manufacturing and formulation management about work scheduling and project progress/results. QCL offers competitive salaries commensurate with experience and an excellent benefits package as well as great potential for career advancement and leadership in a rapidly growing company.