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11825
Contract

Manufacturing Associate III

Location: Cambridge , Massachusetts

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

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
     

Description:

Overall executional responsibility for Nanoliposomal molecules, to ensure that all products are manufactured safely and adhere to cGMP at all times.

Training
• 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
Quality Systems
• 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
Documentation
• 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.
Batch Ownership
• 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)
Miscellaneous
• 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.

 

Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

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