Process Development Validation-Raw Material Associate
Avecia: Milford, MA, Massachusetts, US
About this opportunity :
Process Development Validation-Raw Material Associate provides support to Avecia’s chemical raw material onboarding programs, including the Vendor Assurance Committee, and manage inventory databases.
Key Job Responsibilities:
- Process Chemistry support for the development and improvement of raw materials specifications with responsibility for managing the raw material management databases.
- Support identification of trends and action plans obtained from raw material release testing data.
- Process chemistry support to writing, reviewing, and revision of vendor assessment plans and reports.
- Responsible for reviewing new Process Validation protocol and report documents to support process development, manufacturing and validation activities.
- Review executed MFG batch records and PD experiment records to extract data for CPV and CSR activities.
- Process chemistry support to supplier audits and on-site supplier capability assessments when applicable.
- Support writing and maintenance of formal documents providing justification for specifications applied for release of raw materials.
- Coordinate raw material planning activities and raw material/engineering part inventory systems involving transactions in SAP.
- Report status of assigned activities to project teams and to Validation / Raw Material Development leadership on a weekly basis or as needed.
- Maintain an appropriate level of training on company and departmental procedures as determined by Avecia Raw Material Development.
- Adhere to all company environmental, health and safety policies to support raw material handling, storage and distribution practices.
Job Knowledge Required:
- BS in Scientific Discipline and 2 years of experience in related field within a chemical development or manufacturing environment.
- Sufficient knowledge of organic chemistry procedures, concepts, and literature.
- Demonstrated proficiency in preparation of technical reports and publications in English language.
- Experience in cGMP preferred.
The annualized salary range for this role is $68,000-$83,000.