QA Specialist I
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries.
It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.
In order to continue our organic growth, we are constantly looking for talent.
The Quality Assurance Specialist I fulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training.
Review validation protocols, data and reports, as assigned
Coordinate assigned quality systems, such as GMP training program, deviations, CAPAs, or change controls
Perform annual product quality reviews and system reviews as assigned
Review raw material records
Provide support to customer and regulatory audits.
Conduct internal audits as assigned
Implement improvements in quality systems and SOPs
Review and update assigned documents, such as SOPs, including line clearances, and shipment verification, equipment qualification and documentation control
Provide technical assistance on all production & quality systems documents
Organize and update document room files as required
A Bachelor's Degree in Science or related field and a minimum of 1-2 years' experience in the GMP / Manufacturing setting or
Associates Degree in Science or related field and a minimum of 3 years' experience in the GMP / Manufacturing setting
1-2 years' work experience in GMP manufacturing
Experience in GMP manufacturing, Quality Assurance and/or Quality Control
Experience with GMP document control, validation, qualification and calibration
Ability to work in ISO7 and ISO8 control environment and support real time batch record review
Experience in internal auditing as well as working with regulatory agencies
Excellent written and oral communication skills
Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
Detail oriented with the ability to troubleshoot and resolve problems
Ability to work independently and manage one's time
Communicate effectively and ability to function well in a team environment
You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
Nearest Major Market: San Diego