Manufacturing Associate, Massachusetts

Description

Job Responsibilities:

Manage own time and professional development, be accountable for own results and begin to prioritize own workflow.
Cross-functional communication with tech transfer team, quality and engineering as necessary.
Implement {Current} Good Manufacturing Practices, part of GxP} procedures and safe handling techniques for solid dosage processing within the continuous manufacture /PCMM work stream.
Perform Upstream and Downstream operations in clinical Bio-Manufacturing.
Ability to follow Standard Operating Procedures and work under minimal supervision.
Identify and support continuous improvement initiatives and root cause analysis tools.
Generate, assist and execute documentation associated with solid dosage manufacture, such as, working batch record documentation, in-process run sheets.
Complete activities identified as Operator care tasks associated with the maintenance and operation of complex pharmaceutical manufacturing equipment.
Work in electronic systems including QMS, Documentation, Laboratory Information Management System Enterprise Resource Planning (e.g. SAP) etc.
Actively participate in shift exchange activities and communication channels.
Complete training to take part in safety inspections within the facility.
Understand and comply with the policies, procedures and working practices of Environment, Health & Safety and where necessary contribute to the review and implementation of the practices in the plant.

Skills:

Demonstrated experience in a biotechnology manufacturing or laboratory environment
Operational knowledge of computerized systems, Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems
Maintains a safe work environment
Demonstrated capability to work as a team member in a matrix development team
Excellent oral and written communication skills
Strong computer skills in Microsoft Office required, especially MS Word, MS Excel
Understanding scientific principles, ability to think critically and demonstrate troubleshooting and problem-solving skills.
Knowledge of cell culture and downstream processing techniques

Education/Experience:

Highlights

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