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Manufacturing Associate II
Ref No.: 15-04099
Location: Rockville, Maryland
Incumbent is responsible for the drug product operations (Filling, Visual inspection, Labeling, Packaging and Distribution) for Rockville vaccines under GxP requirements. Job activities intended for the manufacturing associate include preparing equipment for use in aseptic filling operation, executing aseptic filling and lyophilization, utilizing isolator technology, performing visual inspection of filled vials, labeling, packaging and distribution of filled vials as per GMP regulations. Other key responsibilities include:
Executing daily tasks such as washing and sterilizing vials and filling components for use in production operations, the inspection of filled, labeled and packaged vials and performing facility and equipment cleaning according to standard operating procedures.
Recording activities in batch documentation and equipment logbooks according to good documentation practices as well as updating and/ or authoring Standard Operating Procedures to optimize production processes.
Timely reporting of equipment malfunction to manufacturing management.
Maintaining an inventory of manufacturing supplies and ordering additional materials as necessary.
Assisting in activities related to other onsite departments such as the execution of validation protocols.
Other duties as assigned by manufacturing management which contribute to the overall success of the site.
Incumbent will operate general manufacturing equipment under close supervision in accordance with current GMPs or standardized procedures and within safety guidelines. Generally receives no instructions on routine assignments while under little or no supervision.  Requires physical demands of lifting up to 50 pounds. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. May involve work with hazardous materials.
Experience: 6 years
Skills: Requires good documentation skills, interpersonal skills and attention to detail. Working knowledge of aseptic technique, GDP, GMP and SOP (preferably in a production setting involving the filling, capping, inspection and labeling and packaging, but not required).  Must have the ability to work flexible schedules within a team environment (able to work off shift hours as dictated by production demands). Must be able to write effectively and be able to record data accurately and legibly. Must have good manual dexterity, demonstrate mechanical aptitude and the ability to perform in a team setting in a controlled environment for long periods of time.            

Education: BS/BA in Biology, Chemistry, or related discipline and 6 years experience in a GMP facility.