Quality Assurance Specialist

QA Specialist (Assoc Specialist, Specialist, Sr Specialist)

Department: Quality Assurance

Summary: This role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities, Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
• Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
• Collaborates with Cross functional teams to resolve issues, complete investigations and maintain compliance.
• Responsible for review and approval of the following types of documents:
• Failure investigations
• Corrective and preventative actions (CAPA)
• Standard operating procedures (SOP’s)
• GxP documents
• Change control documents
• May lead & support root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver.
• Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
• Monitoring and trending metrics associated with site quality systems.
• Actively participate in continuous improvement ideas, initiation, and implementation.
• May participate in internal, regulatory and customer audits.
• May train personnel on quality system processes.
• Perform additional duties as requested.

Education and Experience:

• Assoc Specialist - BS/BA in scientific discipline or related field or equivalent combination of education and experience
• Specialist - BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
• Sr Specialist - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience