Manufacturing Associate in Cambridge, MA

Manufacturing Associate

Duration: 6 months to 1 year

1st Shift: 7:00AM – 3:30PM Mon-Fri

Strong experience of working with any TFF system is a must

 Produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment.

Responsibilities include, but not limited to operation and performance on equipment used in the manufacturing unit processes.

• Perform the weighing of manufacturing ingredients and the manufacturing of the intermediate formulations.
• Tasks include documentation, data entry, and computer software with compliant systems --Participation in continuous safety and environmental inspections
• Maintain continuous inventory control using computerized system.
• Must be willing and able to work in rotating shifts, extended periods, and/or overtime when required.

Your Role: 

• Follow aseptic procedures and good documentation practices.
• Follow production schedule and prepare materials for production runs.
• Prepare solutions per production schedule.
• Cleaning, operating, and maintaining GMP equipment.
• Prepare equipment for processing by performing cleaning-in-place (CIP) and cleaning-out-of-place (COP), as necessary.
• Perform equipment inspections to ensure readiness and preventative maintenance, as needed.
• Operate and monitor GMP equipment, adjust equipment controls, perform actions as specified by production batch records (BPRs), adhere to aseptic behaviors, and maintain a safe and clean work environment by following cGMPs.
• Document production by completing forms, reports, logs, and records of equipment batches.
• Maintain up-to-date training records.
• Perform cleaning of production suites daily and as necessary.
• Create and edit production records and documents, as necessary.
• Work with environmental monitoring to maintain a clean and safe work environment.
• Ability to lift up-to 20lbs.
• Additional duties and responsibilities as required.

Background: 

• Associate degree in an area of life sciences with a minimum of 2-3 years of experience in manufacturing production or Bachelors’ degree in an area of life sciences with 2-3 years of experience in manufacturing production preferred.
• Experience or understanding of pharmaceutical development preferred.
• Knowledge of cGMP, GDP, USP, and FDA quality guidelines and regulations preferred.
• Process organizational skills to ensure production batch completeness preferred.

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