Alphanumeric is hiring a BIOPHARM MANUFACTURING ASSOCIATE to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements
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.
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.
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.
* Effective oral and written communication skills required.
* Experience or understanding of pharmaceutical development preferred.
* Knowledge of cGMP, GDP, USP, and FDA quality guidelines and regulations preferred.
* Process organizational skills to ensure produ