Department: Azzur of NE, LLC
Azzur Group is looking for an Supervisor, Manufacturing Operations Upstream for an exciting project in Massachusetts
Lead employees on the manufacturing floor within a process team to meet the site goals and priorities. Provides daily job assignments with manufacturing staff and other cross functional departments
- Supervise/Execute cGMP production activities to support the upstream production activities. Maintain a high degree of visibility and access to employees throughout the shift
- Ensures the proper and timely development and training of employees. Responsible for performance management of 3-4 direct reports (Manufacturing Associates).
- Perform deviation investigations, review of documentation including batch records, logbooks and forms.
- Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies.
- Interface with the Quality Assurance, Maintenance, and Materials Management departments to resolve production, supply, and equipment issues. Document issues through deviations, as necessary
- Manage or own quality systems including deviations, CAPA’s, change controls, DCC’s, etc.
- Develop technical expertise in area of responsibility and provide technical instruction/training on current and new/improved processes to appropriate audiences, primarily Manufacturing Associates. Ability to work aseptically in a BSC.
- Assist the Validation and Maintenance staff with the operation and execution of engineering projects. Provide technical expertise for these projects.
- Implement and reinforce practices that make safety an ongoing consideration for all operational activities leading to a safe and clean room working environment. Attend all safety training and exercise self-discipline to follow all EHS policies.
- Provide support to integrate best practices, where appropriate, into manufacturing. Support process improvement initiatives.
- Bachelors Degree in Science or related field with minimum of 5 years experience in cGMP or regulated environment
- A minimum of 2-3 years of supervisory responsibility in a GMP Biotech environment is preferred
- Knowledge of cGMP and CFR requirements
- Strong communication skills: oral/written and listening
- Personal Competencies: Self-awareness, Integrity, Team player, Creative, Highly Motivated
- Must be able to work in a complex matrixed environment
- Must be able to influence without authority across various departments