Ensure compliance and maintain Good Manufacturing Practices (cGMP) by assisting with writing, updating, and review of all the Master Production Records, batch records, standard operating procedures, validations, protocols. Perform specific tasks efficiently and accurately as requested by Quality Assurance Manager/Supervisor before, during and after production. Implement and verify compliance during the production process.
- Maintain current Good Manufacturing Practices (cGMP) and ensure compliance
- Input, type, and update all Master Productions Records, SOP's, Validations, protocols, QA forms according to the guidelines set out by the Quality Assurance Manager.
- Use relevant information and individual judgment to determine whether events or processes comply with regulations or standards.
- Request, update and assist in the evaluation of Safety Data Sheets (SDS).
- Manage and control documents.
- Get along with fellow coworkers and build a team environment.
DUTIES AND TASKS
- Verify Standard Operating Procedures in accordance with the Federal Laws and regulatory bodies that govern each particular type of manufacturing and write and review them for use by ABS Corporation.
- Maintain files for label control.
- Create certificates of analysis for products.
- Maintain file for Corrective and Preventive action (CAPA) program and complaints.
- Participate in the annual review of drug products.
- Work cooperatively in a team environment.
- Some secondary education in Chemistry or related field but prefer a BS/BA in Chemistry or related field with strong math skills with 1-2 years of experience in a pharmaceutical/food manufacturing environment.
- Must have the ability to lift 25-50 lbs.
- Must have Microsoft Office computer skills.
- Highly organized and detail oriented individual.
- Technical writing skills