What are the responsibilities and job description for the Manufacturing Specialist position at Aditi Consulting?
Summary : The Manufacturing Technical Specialist will provide support for Manufacturing Management and Associates to meet batch record review / disposition schedule to adhere to lot release dates. The Manufacturing Technical Specialist will be responsible for, executing root cause investigations, owning / authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.The Manufacturing Technical Specialist role is critical to our patients. Manufacturing life-saving medicines right the first time with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role! Job Responsibilities : Initiates Quality Records and conducts deviation investigations that meeting both Industry and expectations.Leads or manage investigations including root cause analysis and assesses product impact using input from various departments.Develops, executes and oversees CAPAs.Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.Supports Tech transfer and process monitoring support as needed.Works with the team to monitor critical process parameters.Revision and management of manufacturing documents such as Batch Records and SOPs.Leads or supports Continuous Improvement projects.Conducts data gathering, trending, and data presentation as needed to support investigations.Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report. The CandidateBachelor’s degree in a science or engineering field and 4 years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)Previous experience operating equipment such as : incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment3 years of experience in process deviation investigations and remediationAbility to perform interviews and familiarity with root cause analysisPrevious experience authoring and / or revising technical documentsAbility to support and / or lead system troubleshooting effortsKey leadership attributes : Leads with Integrity and RespectDelivers ResultsDemonstrates Business AcumenFosters Collaboration and TeamworkChampions ChangeEngages and InspiresCoaches and Develops Position BenefitsPotential for career growth within an expanding teamDefined career path and annual performance review & feedback processCross-functional exposure to other areas of within the organizationMedical, Dental, Vision, and 401K are all offered from day one of employment19 days of paid time off annually 8 paid holidaysGain experience in the cutting-edge gene therapy spaceTuition Reimbursement Compensation : The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements). Benefits and Ancillaries : Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee. Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. #AditiConsulting
