Support the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provide quality oversight for terminal sterilization, visual inspection, labeling and packaging Operations of parenteral drugs. Perform the quality release of incoming materials. Review documentation and quality records.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations
- Review executed batch records and other associated controlled documents
- Perform clearances and start-up activities associated with Finishing Operations and Weigh and Dispense Booth operation.
- Perform QA review and approval of stability and finished products testing certificates of analysis
- Perform QA review and material release for incoming materials
- Perform routine tasks within the quality systems, such as Work Orders, Calibration Forms, etc.
- Understand and be able to perform job responsibilities in compliance with cGMPs, company standard operating procedures, and industry best practices.
- Participate in deviation investigation teams to support quality investigations (NCRs, LIRs etc.)
- Open to a flexible and fluid work environment.
- Support Agency, customer and vendor audits as needed.
- 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.
- Identify and suggest areas for improvement.
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.