Weekend MSAT Technical Services Specialist

Simtra BioPharma Solutions

Bloomington (IN)

Sur place

USD 70 000 - 100 000

Plein temps

14 jours+

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Un CV et une lettre de motivation personnalisés, prêts à envoyer.

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Avantages offerts par ce poste

Medical & Dental Coverage
401(k) Retirement Savings Plan with Co
Paid Holidays
Paid Time Off
Paid Parental Leave and more

Résumé du poste

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Technical Services Floor Support Representative to join the MSAT team for 100% onsite support. The role is a full-time weekend position, Fri–Mon, four 10-hour days, reporting to the Sr. Manager, Technical Transfer.

You will support aseptic processing, participate in deviation investigations, and coordinate with QA/QC and Manufacturing to meet regulatory release criteria.

Qualifications

  • BS/BA degree in science or engineering or 4+ years of pharmaceutical experience.
  • Knowledge of quality operating procedures and regulatory requirements.
  • Knowledge of systems and equipment including aseptic formulations and QC/QA.
  • Ability to work independently on projects and tasks with strong problem solving.
  • Strong written and verbal communication across multiple functions.

Responsabilités

  • Make and deliver accurate decisions for projects, questions, and requests.
  • Escalate issues for corrective action to the appropriate manager or director.
  • Coordinate with QA/QC and Manufacturing to align projects and information.
  • Assist with deviation investigations and TSS studies.
  • Troubleshoot and test, including PUPSIT, and provide aseptic processing expertise.
  • Evaluate product impact and advise on release criteria per regulatory constraints.

Connaissances

Quality procedures knowledge
Critical thinking
Problem solving
Technical communication
Independent work
Microsoft Office Suite
Minitab
Enterprise software literacy

Formation

BS/BA in science or engineering
Pharmaceutical industry experience (4+ years)

Outils

MS Office Suite (Word, Excel, Outlook)
MiniTab
D365
BPLM
Pilgrim
Trackwise

Description du poste

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Technical Services Floor Support Representative to join the MSAT team for 100% onsite support. The role is a full-time weekend position, Fri–Mon, four 10-hour days, reporting to the Sr. Manager, Technical Transfer.

You will support aseptic processing, participate in deviation investigations, and coordinate with QA/QC and Manufacturing to meet regulatory release criteria.

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