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Job Requirements of Viral Downstream III (VOP):
-
Employment Type:
Contractor
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Location:
Swiftwater, PA (Onsite)
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Viral Downstream III (VOP)
Careers Integrated Resources Inc
Swiftwater, PA (Onsite)
Contractor
Job Title: Viral Downstream III (VOP)
Location: Swiftwater, PA 18370
Duration: 12 Months+ contract (Possible Extension)
Departments Include:
Key Responsibilities:
Requirements:
Additional Information:
Years of Experience: 6 - 9 Years
Position: ANTIGEN
Location: Swiftwater, PA 18370
Duration: 12 Months+ contract (Possible Extension)
Departments Include:
- Clarification: Concentration/diafiltration processing and CIP tanks. General work includes filter testing, housing, sonication, set up tanks/filter assemblies.
- Purification: Sonication, build assemblies, preps receiving tanks, sanitize and load bowls for centrifugation, calibrate in-line refractometers.
- Splitting: Assemble and prep equipment, CIP/prep tanks, centrifugation. General area activities include sonication, building tanks, testing filters.
- Inactivation: Clean/prep skid for processing, run diafiltration/concentration per established parameters.
- Sterile Filtration: Set up tanks and filter trains for process, pull/dispense samples, pre/post use filter integrity testing.
Key Responsibilities:
- Performs production in accordance with volume fluctuation, business need, and effective cGMP procedures.
- Ensures all materials required for production are available prior to use.
- Completes sampling and corresponding documentation as required.
- Completes move tickets and pick lists in an accurate and timely manner to ensure accurate inventory.
- Participates in all aspects of inventory management (SAP, cycle counting, ordering, etc.).
- Identifies all production issues and relays them to the management team.
- Works to prepare assigned areas for the oncoming shifts.
- Completes tasks and corresponding documentation as required by cGMP.
- Follows all procedures to ensure safety of self and others.
- Participates in monthly safety meetings.
- Reports all safety issues, concerns, incidents, and near misses to the team management.
- Follows effective procedures to ensure the production of a safe and efficacious product. Adheres to all SOPs and cGMPs.
- Identifies areas of deficiency to the management team and offers potential suggestions for improvements.
- Participates in deviation investigations when appropriate and implementation plans to ensure a quality product.
- Works with the management team to complete deviation investigations and root cause analysis.
- Works to complete quality documentation (BPRs, logbooks, etc.) accurately in a timely manner. CFR (Code of Federal Regulations) / PAI inspection readiness. FDA audit understanding and awareness.
- Participates in cross-functional teams where necessary to complete projects in an effective and timely manner.
- Performs all other duties as assigned.
Requirements:
- Strong self-driven work ethic with communication and time management skills.
- Commitment to personal and professional development by completing and giving training.
- Adaptability to work in a fast-paced/changing work environment.
- Attention to details, ability to follow instructions.
- Good documentation skills, legible handwriting.
- Basic mathematical skills and computation ability.
- Ability to work independently and in a group.
- Must have basic mechanical aptitude, computer skills, comprehension, and retention skills.
- Troubleshooting and manual dexterity required.
- Thorough knowledge of cGMPs and regulatory requirements are required.
- Ability to lift up to 50 lbs.
- Bachelor's Degree preferred.
- Previous production experience preferred.
Additional Information:
- Hours 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.
- 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: 6 - 9 Years
Position: ANTIGEN
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