Manufacturing Associate II Job at BERKSHIRE STERILE MANUFACTURING LLC in Lee

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 and routine manufacturing activities.

Duties and Responsibilities

• Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
• Operation manual, semi-automatic and fully automatic isolated based aseptic filling lines
• Perform aseptic operations in Clean Room environments
• Prepare buffers, medias and other solutions, following written procedures and batch records
• 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 assigned 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

☐ Manufacturing Associate I – Zero to two (0-2) years’ experience in a GMP environment and in an approved laboratory under minimal supervision preferred

☐ Manufacturing Associate II – Three to four (3-4) years’ experience in a GMP environment and in an approved laboratory under minimal supervision preferred

Education

☐ Manufacturing Associate I – Associates or Bachelors’ Degree in a science-related discipline or equivalent GMP experience

☐ Manufacturing Associate II – Bachelors’ Degree in a science-related discipline or equivalent GMP 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