Support the quality systems as they relate to the manufacturing and testing of cGMP drug products, including the review of documentation and quality records associated with filling, terminal sterilization, visual inspection, labeling and packaging.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Verify compliance with filling, terminal sterilization, visual inspection, labeling and packaging operations documentation.
- Review executed batch records and other associated controlled documents
- Perform QA review in-process and environmental monitoring test results
- Perform job responsibilities in compliance with cGMPs, company standards operating procedures, and industry best practices.
- Open to a flexible and fluid work environment.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
- Ability to complete tasks with accuracy and efficiency.
- Ability to understand quality standards.
- Portrays appropriate levels of integrity and professionalism.
- Basic written and verbal skills; Ability to communicate with management and staff.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Develop an understanding of the decision-making process and begin to build confidence in decision making ability.
- Ability to work independently and in a cross-functional team environment.
- Must have basic computer skills such as Microsoft Word, Excel and Outlook.
Qualified candidates have knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment. This level of knowledge is normally acquired through completion of a Bachelor’s Degree in Life Sciences or related field, and 1-2 years related work experience. In lieu of a Bachelor’s Degree, equivalent GMP/related work experience may be considered.