4609 Qc Analyst I

Main Purpose of the Position

• Provide direct manufacturing Quality Assurance support for all GMP activities at HTO/HDC.
• Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support.
• Assure compliance with cGMP regulations, the Company’s standards, and applicable Regulatory and the Company’s standards.
• Resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations
• Perform assigned tasks and work to achieve company goals and department objectives.

Job Duties/Responsibilities

• Advocate for Roche’s mission of advancing and boldly championing diversity, equity, and inclusion
• Follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Meet assigned targets and timelines with minimal supervision.
• Prioritize assigned tasks within a fast paced environment.
• Participate in process improvement and system design teams.
• Provide assistance to customers in support of departmental functions.
• Work with colleagues to maintain cross-functional and cross-site process and procedural consistency.
• Receive specific instruction and work independently to complete tasks.
• Apply basic theory and technical principles to address routine problems.
• Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Sign documents for activities as MQA as described by the Company’s policies, procedures, and job descriptions.
• Be accountable for behaviors as described in the Company’s Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities

• Perform Inspection and Packaging AQLs. Perform Line Clearance activities in conjunction with Manufacturing.
• Initiate and close Unplanned Event (UPE) records and action/assessment records as required.
• Review batch records in the Aseptic Operations, Inspection, and Packaging areas.
• Complete Additional Actions in the Discrepancy Management System as assigned.
• Interact with interdepartmental contacts on discrepancy assessment and resolution.
• Provide Quality oversight to internal and external customers.
• Review and approve controlled documents relating to processes, equipment, facilities, and utilities in the manufacture of products.
• Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
• Support Quality process improvement initiatives.
• Support the execution of departmental deliverables assigned by project teams or governance teams as required.

Qualifications: 

• Education, Experience, Knowledge, and Skills
• B.A. or B.S. degree (preferably in Life Science) or equivalent in a related industry
• Ability to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning.
• Knowledge of cGMPs or equivalent regulations is strongly preferred.
• Experience reviewing manufacturing documentation.
• Ability to interpret and relate Quality standards for implementation and review.
• Ability to independently evaluate situations and propose potential solutions.
• Ability to communicate clearly and professionally both in writing and verbally.
• Flexibility in problem-solving, providing direction and work hours to meet business objectives.

Compensation Range: $25 to $30/hr

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