Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing
laboratory in Wilmington, is seeking a qualified candidate for the position
of Technical Services Associate.
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.
