Biological Services II (1st Shift)

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