Manufacturing Associate (All shifts)

Production OperationsPerform 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 autoclavePrepare buffers, medias and other solutions, following written procedures and batch recordsOperate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipmentPerform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualificationAdhere to scheduling changes and responds appropriatelyCommunicate with supervisor on issues regarding work orders or shifts in process parametersGive input and make suggestions to improve processFollow all GMP's and EHS proceduresAttend and completes all mandatory trainingEnsure training plan is accurate and up-to-dateComplete all necessary documentation per the required GMP practicesParticipate in presenting the manufacturing areas in a state of audit readinessPerform production operations following written SOP's/BR's in accordance with GMPsOther duties as assignedRegulatory Responsibilities:Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicableSupervisory Responsibilities:N/AExperience:Experience in a GMP environment and in an approved laboratory under minimal supervision preferredEducation: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 experienceKnowledge, Skills & Abilities:Understanding of the basic FDA cGMP regulationsVerbal and written skillsBasic software application skills (Word, Power Point)Able to follow detailed processing instructionAccurately document all necessary documentationSatisfactory audio-visual acuityAbility to read and write EnglishFamiliarization with technical issues in the areaAbility to work shift that covers a 24/7 operationAbility to work shifts and off hours, as applicablePhysical Requirements:Ability to sit or stand for prolonged periods of timeAbility to lift and carry materials weighing as much as 50lbs