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
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Operate glass washers and autoclave
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Prepare buffers, medias and other solutions, following written procedures and batch records
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Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
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Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualification
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Adhere to scheduling changes and responds appropriately
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Communicate with supervisor on issues regarding work orders or shifts in process parameters
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Give input and make suggestions to improve process
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Follow all GMP’s and EHS procedures
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Attend and completes all mandatory training
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Ensure training plan is accurate and up-to-date
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Complete all necessary documentation per the required GMP practices
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Participate in presenting the manufacturing areas in a state of audit readiness
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Perform production operations following written SOP’s/BR’s in accordance with GMPs
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Other duties as assigned
Regulatory Responsibilities
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Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable
Supervisory Responsibilities
Experience
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Experience in a GMP environment and in an approved laboratory under minimal supervision preferred
Education
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Associates Degree or High School Diploma with zero (0) to two (2) or more years of directly related experience.
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Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience
Knowledge, Skills & Abilities
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Understanding of the basic FDA cGMP regulations
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Verbal and written skills
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Basic software application skills (Word, Power Point)
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Able to follow detailed processing instruction
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Accurately document all necessary documentation
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Satisfactory audio-visual acuity
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Ability to read and write English
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Familiarization with technical issues in the area
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Ability to work shift that covers a 24/7 operation
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Ability to work shifts and off hours, as applicable
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Ability to sit or stand for prolonged periods of time
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Ability to lift and carry materials weighing as much as 50lbs
