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Associate Scientist
Associate ScientistSPECTRAFORCE • Swiftwater, PA, US
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Associate Scientist

Associate Scientist

SPECTRAFORCE • Swiftwater, PA, US
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  • [job_card.full_time]
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Job Description

Position Title : Viral Downstream III

Work Location : Swiftwater, PA

Assignment Duration : 12 Months

Work Schedule :

  • 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.

Work Arrangement : (no explicit single-line statement present in raw JD)

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.
  • 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.

    • 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 past / 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 50lbs.
  • Bachelor's Degree preferred.
  • Previous production experience preferred.
  • 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.
  • 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 : 6 - 9 Years
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    Associate Scientist • Swiftwater, PA, US

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