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