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Manufacturing Associate 2nd & 3rd shift

Manufacturing Associate 2nd & 3rd shift

BERKSHIRE STERILE MANUFACTURING LLCLee, MA, US
16 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Position Summary

Perform all production operations in the areas assigned within the facility. Perform production support operations in areas assigned and support start-up, changeovers and tech transfer activities.

Duties and Responsibilities

  • Operate glass washers and autoclave
  • Prepare buffers, medias and other solutions, following written procedures and batch records
  • Operate process equipment such as tanks, clean in place skids (CIP / SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
  • Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training / qualification
  • Adhere to scheduling changes and responds appropriately
  • Communicate with supervisor on issues regarding work orders or shifts in process parameters
  • Give input and make suggestions to improve process
  • Follow all GMP’s and EHS procedures
  • Attend and completes all mandatory training
  • Ensure training plan is accurate and up-to-date
  • Complete all necessary documentation per the required GMP practices
  • Participate in presenting the manufacturing areas in a state of audit readiness
  • Perform production operations following written SOP’s / BR’s in accordance with GMPs
  • Other duties as assigned

Regulatory Responsibilities

  • Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable
  • Supervisory Responsibilities

  • N / A
  • Experience

  • Experience in a GMP environment and in an approved laboratory under minimal supervision preferred
  • Education

  • Associates Degree or High School Diploma with zero (0) to two (2) or more years of directly related experience.
  • Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience
  • Knowledge, Skills & Abilities

  • Understanding of the basic FDA cGMP regulations
  • Verbal and written skills
  • Basic software application skills (Word, Power Point)
  • Able to follow detailed processing instruction
  • Accurately document all necessary documentation
  • Satisfactory audio-visual acuity
  • Ability to read and write English
  • Familiarization with technical issues in the area
  • Ability to work shift that covers a 24 / 7 operation
  • Ability to work shifts and off hours, as applicable
  • Physical Requirements

  • Ability to sit or stand for prolonged periods of time
  • Ability to lift and carry materials weighing as much as 50lbs
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