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Title: Manufacturing Associate
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Manufacturing Associate
Compensation, Benefits, and Employment Type
- Duration – Contract – 12 months+
- Pay rate: 40-50/hr.
- Job Location: Cambridge, MA
- Job# bh11825
- Date Posted: 10/28/2020
Overall executional responsibility for Nanoliposomal molecules, to ensure that all products are manufactured safely and adhere to cGMP at all times.
• Ongoing maintenance of own training within compliance wire to ensure training has taken place in all aspects of the production activities within the assigned area including OJT requirements
• Obtain a thorough knowledge of the NLF systems and relevant quality systems to enable efficient production including CAPA, Change Control and Quality Incident initiation and closure
• Operate the Change Control System, Quality Incident System and other validation procedures
• Ensure high standards of cGMP are adhered to at all times
• Assist QA and manufacturing management in Lot Disposition activities
• Carry out the manufacturing review (as delegated) of the completed batch record/logbooks in a timely manner per established targets
• Participate in validation activities as required
• Support the creation, revision, and/or completion of Change Control forms, Quality Incidents and cGMP documents, ie: Batch records, SOP
• Ensure high standards of documentation completion are adhered to at all times
Plant and Process
• Ensure all required materials and documentation are available for the processing start date.
• Demonstrate a thorough and complete understanding of safety requirements, and cGMP compliance of the plant and process
• Strive to become fully trained in all aspects of production operations for all equipment in the primary area of responsibility
• Operational knowledge of Clean rooms, TFF, Column Chromatography, Final Bulk Fill “aseptic” operations.
• Identify any continuous improvements to the process/equipment, and drive through to completion any projects for which have been assigned.
• Ensure all relevant documentation is available as required for the process
• Understand the status of the batch at all times with relation to lot review, QI’s etc.
• Drive completion of lot review, deviations, change controls if applicable prior to batch disposition (as delegated by Team Leader)
• Ensure high standards of housekeeping and safety policies are adhered to within the facility
• Highlight safety issues in the area and embrace a right first time culture.
• Effective communication with other departments and maintain positive relations at all times.
• Ensure projects and objectives are met in the appropriate agreed to timescale.
• Remain flexible and ready to train and support NLF operations as required and driven by the master production schedule
1. A.S. or B.S. with minimum 4+ years of post-degree hands-on experience in GMP manufacturing or Process Development, or GMP equivalent industry experience
2. Must have a strong working knowledge of basic protein purification, cell culture or nanoliposome manufacturing processes
3. Must be able to review batch records and SOP’s and other support documentation.
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