Manufacturing Associate- 2nd Shift

Found in: Talent US C2 - 2 weeks ago

Lee, United States Berkshire Sterile Manufacturing Full time

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
(Sun-Tue) 2:30pm- 2:00am
(Wed - Fri) 2:30pm - 2:00am
10% SHIFT DIFFERENTIAL

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