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Viral Downstream III (VOP)
Viral Downstream III (VOP)Careers Integrated Resources Inc • Swiftwater, PA, United States
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Viral Downstream III (VOP)

Viral Downstream III (VOP)

Careers Integrated Resources Inc • Swiftwater, PA, United States
Hace 12 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Job Title : Viral Downstream III (VOP)

Job Location : Swiftwater, PA

Duration : 12 months+ (Possibilities of Extension)

Shift : 1 st Shift, 2 nd Shift, 3 rd Shift

Job Description :

  • 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

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.
  • Follow all procedures to ensure safety of self and others.
  • Participates in monthly safety meetings.
  • Report 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.
  • Adhere to all SOPs and cGMP's.
  • Identifies areas of deficiency to the management team and offers potential suggestions for improvements.
  • Participates in both 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 (BPR's, logbooks, etc.) accurately in a timely manner.
  • CFR (code of federal regulations) I PAl inspection readiness. FDA audit understanding and awareness.
  • Participates in cross functional teams where necessary to complete projects in an effective and timely manner.
  • All other duties as assigned.
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    Downstream • Swiftwater, PA, United States