Operations Specialist

Operations Specialist - IIIPay Rate: $40 - $50/HRCandidate should have past experience with:Drafting/Authoring docs(SOP's and protocols) related to process, safety, aseptic techniques, cleaning operations.Supporting manufacturing facility.Supporting clinical studies and lab activities.Managing inventory system like SAP.Supporting formulation teams within lab.Developing several process improvements plans.Conduct investigation and provide CAPA.Supporting R&D projects whenever needed.Qualifications:Position Overview: The Support Technician is an individual contributor with operational and technical responsibilities. This position has multiple roles that include:Supporting Formulation, Laboratory and Experimentation Center (FLEx Center) activities (CQ&V, author/review SOPs, SAP, etc.).Leveraging experience in drug product manufacturing to support daily manufacturing and cleaning operations (development & GMP activities) within the FLEx Center.Leveraging scientific/technical capabilities to support R&D development program activities as needed.The Support Technician position will flex between roles when necessary to drive program and development needs.Required Experience and Skills:Education Minimum Requirement: B.S. Degree in Science, Engineering or other technical field.Minimum (4-5) years' experience in a functional area, such as Operations, Technical Operations, Technology, Engineering.Minimum (4-5 years' experience in relevant manufacturing or processing (bulk, solid oral dosage, solutions/suspensions, packaging, etc.) with working knowledge of current good manufacturing procedures (cGMP).Software expertise:MS office, Inventory management system like SAP.Personality:Detail OrientedTeam playerIndependentFlexibleNotes:100% onsite role@ Rahway, NJ6 months role with a possibility of extension based on performance and budget.Candidate should have valid work authorization, no visa assistance/sponsorship will be provided.Responsibilities:Incorporate scientific and technical knowledge to complete assigned tasks.Collaborate with internal stakeholders to drive effective communication and completion of deliverables.Understand priorities from manager/supervisor to ensure task completion.Understand/act on guidance from supervisor where decisions are guided by policies, procedures, and business plan.Identify and help to resolve standard day to day quality, technical, and operational problems.Make decisions guided by policies and standard operating procedures.Compliance: Responsible for sustaining a culture of compliance (Safety, Environment, cGMP).Exercise judgement and decision making to ensure quality product is reliably produced.Utilization of Client Leadership Behaviors and Ways of Working to promote daily work activities.Keep informed on current policies/procedures and all other FLEx Center communications.Comply with all safety rules and regulations and take prompt corrective action concerning potential safety hazards.Support compiling safety related documentation requirements (e.g. process waste identification/collection).Help to identify root causes of manufacturing issues and implement corrective action.Author/review documentation related to operational procedures and/or reports.Oversee equipment support, cleaning activities, and the review/approval SOPs and technical documents.Technical support for manufacturing and packaging activities.Support equipment and cleaning processes.Equipment administration management.Adaptive to learn new skills or processes (SAP) to drive functionality of the FLEx Center to meet objectives.Comments/Special Instructions:Not looking for industry-Oil/Automobile/Chemical/Aviation or agriculture.Not looking for PHD candidates.Not looking for supervising/manager experience.Kindly share your resume with answers:How many years of exp in Pharmaceutical /Vaccine manufacturing / cGMP environmentHow many years of exp in bulk, solid oral dosage, solutions/suspensions, packaging, with working knowledge of current good manufacturing procedures (cGMP)How many years of exp in Inventory management system like SAP.How far you live from 126 E. Lincoln Avenue, Rahway, NJ and how will you commute daily