Georgia Employer MANUFACTURING OPERATIONS ASSOCIATE in Union City, Georgia

DendreonUS-GA-Union CityJob ID 2018-1271Category ManufacturingOverviewThe Manufacturing Operations Associate is responsible for Aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room environment (Class 10,000/ISO7, and Class 100,000/ISO8).ResponsibilitiesResponsibilities:Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.Represents department in cross-functional teams, projects and GXP-related problem resolution.Posts weights and shipping charges, and prepares goods for final shipment.Prepares and maintains records of merchandise shipped.Prepares goods for final shipment and unpacks and checks goods received against purchase orders and invoices, maintains records of received goods, rejecting unsatisfactory items if necessary.Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.Other duties as assignedAbility to work 12 hours shifts.Ability to be flexible and support all functions by readily responding to changing circumstances (i.e.shift changes) and business needs.QualificationsAssociate's or Medical Technical degree or equivalent.Typically 2 years related experience in CGMP/FDA regulated industry or 1 year with Medical Technical degree.Proficient in MS Office applications.Ability to sit or stand for extended periods of timeIntermittent walking to gain access to work areasFinger dexterity sufficient to use a computer and to complete paperwork activitiesVision sufficient to use a computer, to read written materials and to complete paperwork activities;Hearing sufficient to communicate with individuals by telephone and in personAbility to lift up to 25 pounds. Limited exposure to (2�C - 8�C); (-20�C); (-75�C); (-196�C) areas.Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 - 20 lbs and lift up to 50 lbs.May be required to work alternate shiftsAbility to gown aseptically for work in Clean Room environmentsJob performed in a lab, office, or utility (noisy) environmentMust have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.Dendreon is an EEO/AA employer M/F/D/V.Dendreon is an equal employment and affirmative action employer F/M/Disability/Vet/VEVRAA/Sexual Orientation/Gender Identity. EEO Is The Law: Here: