Description
Essential duties and responsibilities include but are not limited to the following:- Perform batch record review activities for products ensuring products meet specifications and are produced and tested in compliance with approved procedures and applicable regulations.
- Compile, organize and file quality records and documentation which include but not limited to executed batch record documentation, manufacturing records, analytical data. package, and labeling and packaging records, and associated documentation.
- Review analytical data and trend, as required.
- Generate key quality performance indicators, collect metrics and perform data trending analysis.
- Participate and support internal audits, external audits and regulatory inspections, as required.
- Assist in Quality Investigations of GMP activities, Generate Incident Reports, Change Controls and CAPA reports.
- Develop and revise Standard Operating Procedures, specifications, validation procedures, work instructions and forms as needed.
- Develop and implement methods and procedures for monitoring work activities Special project as required supporting departmental goals.
- Perform other duties as assigned.
Requirements:
- Minimum of 5+ years biopharmaceutical experience with small molecules, preferably oral solid dosage.
- Ability to work in a fast-paced environment, willing and eager to work in a hands-on capacity is required.
- The ability to collaborate successfully and build relationships with internal teams, suppliers and agencies is required.
- Must have strong computer skills, Microsoft office programs (Word, Excel, PowerPoint, Outlook, etc.).
Education:
- A Bachelor's degree is required.