Address
Form of workPay Rate: *** - *** DOE
A shift which is Sun to Tue with alternating Wed (12-hrs each day) or C shift which is Thu to Sat with alternating Wed (12-hrs each day).
Working hours are 6am to 6:30pm ***
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, Roche/ *** standards, and applicable Regulatory and *** 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 Roches 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 *** policies, procedures and job descriptions.
Be accountable for behaviors as described in ***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 product.
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 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
