Biological Services B46/B56 II (VOP)

Performs production in accordance with volume fluctuation, business need, and effective procedures in the Biological Service Area (BSA). This position is responsible for manufacturing activities in the assigned area. Key responsibilities ?Completes sampling and corresponding documentation as required. ?Completes process order and bin to bin movements in an accurate and timely manner to ensure accurate inventory in SAP.?Participates in all aspects of inventory management (SAP, cycle counting, ordering, etc.). ?Completes tasks and corresponding documentation as required by cGMP. ?Works with Senior and Lead Technicians as well as Managers to ensure an efficient operation. ?Participates in team meetings. Actively communicates improvement ideas, issues, concerns, etc. to team members. Identifies all production issues and relays them to the leadership team. ?Complete tasks such as environmental monitoring and water sampling to be completed. ?Write and edit cGMP procedures and documents under supervision. ?Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product in all areas. ?Ensures proper process area operation by pre and post run set up and maintenance of lab and equipment. ?Works to complete quality documentation (BPR?s, logbooks, etc.) accurately in a timely manner. Requirements ?Strong self-driven work ethic with communication and time management skills.?Commitment to personal and professional development by completing training. ?Adaptability in a changing work environment required to work in an area where various items enter and exit to support facility demands across site.?Attention to details ?Good documentation skills ?Ability to work independently and in a group ?Requires good mechanical skills ?Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity. ?Thorough knowledge of cGMPs and regulatory requirements are required. ?Efficient, 10-hours on feet per day ?Ability to lift 30+ lbs.?Detail oriented and ability to write clearly ?Self-driven and motivated ?Follow cGMP SOP/ SWI?s for compliance ?Ability to work multiple shifts inclusive of weekendsHours for each position may vary. All positions require employees to stay until a job is completed. Every employee must be able to work weekends, holidays and overtime if necessary. Days off may not be consecutive and may vary from week to week (rotating schedule). Working hours are subject to change based on production demand. Employees may be required to take set days off in the middle of the week or work a rotating schedule.All antigen positions involve the production of active viruses. While risk of exposure is minimal, vaccinations are required for all areas, including Flu, Menactra, and Yellow Fever pending area assignment. Jewelry and makeup are not allowed on the floor. Perfume, hairspray, cologne, aftershave and/or any scents are not permitted. Artificial nails and nail polish are not allowed. The attire includes (but is not limited to) sterile scrubs, hairnets, beard covers, safety glasses, steel toe shoes, and in some areas Tyvek suits. Years of Experience: 3 - 6 Years

Antigen