Job Description

Compliance Specialist II

The Compliance Specialist II makes an impact by leading and owning manufacturing investigations, utilizing root cause analysis tools as required to find root cause and contributing factors. Supporting and developing consistent manufacturing/quality standards and/or process for Deviations and CAPAs in Quality Systems. Conducting complex document revisions and/or document management including batch production records and manufacturing procedures.

Responsibilities:

• Identify event impact and communicate/present to Manufacturing and Quality.
• Definition, ownership, and/or support of corrective and preventative actions (CAPA’s) in alignment with Manufacturing requirements.
• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations. 
• Edit cGMP documents and process through workflow for the creation of quality approved documentation.
• Cross-functional collaboration with document control and other supporting groups is required.
• Support manufacturing internal and external observations as required.
• Practice and promote safe work habits while adhering to safety procedures and guidelines.
• Support and develop consistent manufacturing/quality standards and/or process for Deviations and CAPAs in Quality Systems.
• Conduct complex document revisions and/or document management including batch production records and manufacturing procedures. 
• Own and maintain tracking systems of manufacturing compliance priorities.  
• Work collaboratively with others to meet group and organizational goals.
• Participate in initiatives to support innovation and continuous improvement activities.
• Improve compliance within quality procedures, policies, and regulations. 
• Participate in client and planning meetings as requested. Including but not limited to presentation and document preparation. 
• Support manufacturing change control.

Education/Experience

• Bachelor’s degree in sciences, pharma, biotech, manufacturing, or related field.

• 2 years’ experience in pharmaceuticals manufacturing or regulated working environment.
• Manufacturing Operations Experience is preferred.
• May consider additional years of related industry experience in lieu of degree

Knowledge, Skills, and Abilities

• Ability to gown aseptically and/or sterile gown as needed.
• Write, read/review written documentation for extended periods of time.
• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
• Strong planning, organization, and multitasking skills. 
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to make decisions and work with minimal to moderate supervision.
• Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.  
• Solid understanding of applicable regulatory requirements.