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Position Title: Biological Services II (1st Shift)
Work Location: Swiftwater, PA 18370
Assignment Duration: 8 Months
Shift Timings: 6 AM to 2:30 PM
Position Summary:
• 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.
Qualification & Experience:
• 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 weekends.
• 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