Regulatory Compliance Associates (RCA), a Management Consultant Firm in the Life Sciences Industry is looking for Quality Assurance Specialists for a client in the Michigan area. This person will be supporting quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include but are not limited to: providing oversight and general support for the manufacturing of aseptic processes, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, and supporting the Quality Management System.
- Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance
- Establish and maintain good technique with regards to working in classified areas (including gowning qualification)
- Review and approve executed batch records and other associated controlled documents
- Perform QA review in-process and environmental monitoring test results
- Perform QA review and material release for incoming materials
- Perform triage and impact assessment for deviations associated with the aseptic filling process.
- Participate in cross functional teams to support quality investigations
- Perform tasks within the quality systems with an understanding of the correlation between systems, such as the relationship between a deviation and CAPA.
- Perform routine tasks within the quality systems, such as Work Orders, Calibration Forms, etc.
- Identify and participate as a team member in continuous improvement efforts
- Perform job responsibilities in compliance with cGMPs, company standards operating procedures, and industry best practices
- 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
- Perform training of Specialist I’s, as necessary
- Ability to complete tasks with accuracy and efficiency.
- Ability to interpret and relate quality standards for implementation and review.
- Portrays appropriate levels of integrity and professionalism.
- Proficient written and verbal skills; Ability to communicate effectively with management and staff.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Understand processes and ability to relay rationale behind controls in place to team members and others.
- Identify areas for improvement and propose potential remediation
- Results oriented and efficient.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate and understanding of the decision-making process and begin to build confidence in assessing the associated risks.
- Ability to work well independently and in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
- 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 2-5 years related work experience. In lieu of a Bachelor’s Degree, equivalent GMP/related work experience may be considered.