Sr Qc Specialist Jobs

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Essential Duties and Responsibilities:

• Ability to work well independently and with minimum supervision and identify problematic deviations upfront.
• Possesses strong organizational, multitasking, and Technical Writing abilities, with a solid background in manufacturing processes and controls.
• Some travel may be required.
• Conduct risk assessments and provide a commissioning timeline of activities to identify and evaluate and prioritize risks associated with commissioning and qualifying.
• Be able to help lead team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified within area of expertise.
• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards.
• Critically reviews, writes or revises various types of documentation to ensure completeness, accuracy, and compliance including but not limited to manufacturing records for batch and material release, specifications, validation protocols and summary reports, regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, SOPs, master plans, deviation investigations, CAPAs and change controls.
• Assist and provide guidance on any nonconformance, deviation, or excursion that may occur, experience with deviations and CAPAs required.
• Be able to clearly communicate on expertise to internal and external teams when needed.
• Experience with Trackwise and MasterControl preferred.

Requirements:

• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment
• 8-10 years previous experience with quality projects within the biotechnology and pharmaceutical industries.
• Review and approve Standard Operating Procedures (SOPs).
• Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.
• Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
• Reviews and approves Quality, Quality Control, Validation and Automation related documents
• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
• Provides Quality Assurance (QA) support to Devens Site and reporting Manager through quality review and approval of Investigations and Corrective Actions.