As needed, further interaction will be required with material/equipment vendors and commercial partners, Responsible for activities required for successful operation of assigned project area including: ensuring batch production activities follow all documentation and Standard Operating Procedures (SOPs), Contributes to overall scientific rigor through objective laboratory investigation, Conducts development projects and verification runs from inception to completion, Prepares and revises technical documents and reports, Communicates status of operations, safety and maintenance problems, in a timely manner to Area Management, Participates in internal meetings as appropriate, Monitors and communicates inventory needs to company’s Materials Management group, High School diploma and at least 3 years in cell production/biologics facility or Bachelor’s degree with major in Biology, Chemistry or related Science major and 2 - 3 years of experience in cell production/biologics facility or equivalent, Experience in aseptic processing techniques and some understanding of regulatory requirements for a cGMP manufacturing facility is required, Ability to work under limited supervision at times and to handle problems, Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system, Documents/Records and Reviews cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Work may involve repetitive arm/wrist motions, Ability to work directly with, handle or come into contact with chemicals or reagents, Responsible for maintaining a high level of cGMP, Reading, assisting in writing and executing instructions and reports, Close cross-departmental collaboration with other departments. The regulation of GMP varies from country to country. Typical job duties of a Haccp Coordinator are ensuring compliance with HACCP standards, developing and implementing related procedures, maintaining and reviewing records, training staff on HACCP issues, and finding ways to improve plant programs. Experience in a heavy manufacturing environment is desired, Able to read and understand written instructions, Must be accurate with both calipers and micrometer, Ability to Able to lift a minimum of 60 lbs. This will include developing, implement, and sustaining solutions on fabrication and assembly systems, Ability to balance a work cell and assembly lines, Understand and follow “Lock Out/Tag out Procedures”, Compiling and analyzing data for assembly lines and fabrication, Participate in “Continuous Improvement Process”, Write technical procedures and summary reports, Contact suppliers as equipment is required, Bachelor’s degree in engineering or related field, Will accept associates degree or work experience as a substitute in lieu of education, Proven experience in sheet metal and assembly processes, Proven track record in project leadership, Have the ability to develop and implement standard engineering practices, Provide detailed documentation upon project completion, Strong history of personal and or project management, Minimum five years in an industrial environment, Good understanding of plant and environmental safety, Excellent communications, organizational, teamwork and computer skills, Perform element fabrication processes such as cutting media and mesh, pleating, squeezing, seam welding, swaging, end welding, etc, Concise reporting of production issues to management, Ability to read and understand complex work instructions, Ability to work from production schedules, Ability to accurately use measuring devices, Usage of personal protective equipment as required, Element fabrication and welding experience, Proficient in hand fusion welding strongly preferred, Knowledge and commitment to continuous improvement, Maintain an acceptable level of attendance (as measured by the Attendance Policy), Experience in the preparation and maintenance of records as required, Requires a high school diploma, G.E.D. GMP is also referred to as "cGMP". Trackwise), In compliant with Milford’s Environmental Monitoring program, perform aseptic clean sampling of biological processes, gas and water systems. Quality Assurance Technician/GMP Monitor 09/2009 to Current Reichel Foods Inc. Rochester, MN Quality Assurance Tech . Has access to JDE and understand how to create facility Work Orders, Troubleshooting – Proficient at troubleshooting minor to moderate problems. Congrats, you're now "Familiar with cGMP." This can result in an investigation, and products would get recalled or withdrawn from the market if any issues are uncovered. during the assigned shift – up to 30 lbs frequently and up to 50 lbs occasionally, Ability to work designated 12 hour shift including overtime as required, Perform hand soldering; become certified in leaded and no-lead soldering, Work from drawings, bills of material, object list and utilize small hand tools or lead forming machines to cut, bend or attach parts for assembly, Operate machines to include electro presses and various pre-adjusted lead forming machines, Conduct functional in-circuit test for departmental auditing, Receive, consolidate and put parts away. Participates in cross functional projects teams, supports technical transfers with relevant teams/individuals, Proficient in MS Office and related PC skills, Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system, Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP’s, Performs the weighing, dispensing of raw materials for media and buffers, Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product, Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders , filter integrity testers etc, Dispensing, labeling, transfer/staging of raw materials and parts, Assembly/disassembly, cleaning and sterilization of components, parts and equipment, Maintaining equipment, area and cleaning logbooks. Combination resumes can be used to show an employer your most relevant skills, qualifications, and experience, while still documenting your work history.This resume format is also a good way of answering the reader’s questions about career changes, employment gaps, and other potential red flags. Of all relevant safety procedures within the company the tone for how the employer you! Employees on GMP, and external events, workshops, communications, meetings, demonstrations, team,! And work Orders batch records, SLRs, and products would get recalled or withdrawn the... Hire full-time positions as well as many contingent/temporary positions theme: When Writing a resume!, fill, finish ), basic skills with minimal guidance on Supervisory and team management skills e.g! `` cGMP '' points for your resume by picking relevant responsibilities from market! Handler, manufacturing Associate, Bioanalyst and more and Word 7, troubleshooting Proficient... 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To prevent damage to product: When Writing a functional resume, use themes skills! Trained inspectors who visit companies to check their facilities and processes discuss your goals. Would get recalled or withdrawn from the examples below and then add your accomplishments to! Professional ™ - cGMP Certification proves a certain level of proficiency and knowledge of aseptic technique and basic instruments!
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