Biologics Manufacturing Process Specialist

7 days ago

Brisbane, Queensland, Australia Thermo Fisher Scientific Full time

Job Summary

The Biologics Manufacturing Process Specialist will assist with the review of critical quality documentation and provide a strong pathway to amend compliance-related issues. The role will transact ERP manufacturing data and control the flow of raw material to Production Areas.

Key Responsibilities:

  • Work with the MBP Team to close production tasks daily, after reconciling and adjusting raw material, waste, and finished goods inventory.
  • In conjunction with production schedules, ensure the timely arrival of all material requirements from external warehouses.
  • Perform root cause investigations on material stock discrepancies.
  • Review expiring materials reports to mitigate stock shortfalls and material write-offs.
  • Deliver sustained improvement in site key performance indicators of Right the First Time and On-Time Delivery.
  • Review and approve manufacturing production protocols in a timely manner.
  • Propose Corrective and Preventive Actions and support the timely closure of quality records.
  • Perform any reasonable additional tasks required for day-to-day operational activities.

Frequent Contacts:

Internal

  • QA, QC, USP, DSP, MBP, Tech Transfer, VAL, ENG, EH&S, and WHS

External

  • External Auditors and Customers

Minimum Requirements/Qualifications:

Qualifications & Experience

  • >1 year of data administration in a pharmaceutical or FMCG field desirable
  • Previous experience in raw material inventory control desirable
  • Experience with ERP systems, SAP preferred
  • Experience with SmartSheets desirable
  • Experience with PowerBI Reporting desirable
  • Understanding of business processes

Skills & Attributes

  • Knowledge of cGMP working environments desirable
  • High levels of accuracy, initiative, problem-solving skills, and a strong attention to detail
  • Proficiency in Microsoft Office and data entry software
  • Excellent oral and written communication skills, as well as social skills

Other Important Information:

The Patheon Biologics site (Part of Thermo Fisher Scientific) in Brisbane manufactures many products for clinical trials and commercial applications. This implies that the production activities range from completing a totally new production run to the routine production of a commercial batch. Due to the diversity of customers and their associated products, the applicable processing steps are very diverse. Given the high value of the products and intermediates, the Bioprocess Scientist must be capable of judging the possible impact of a situation on product quality, yield, EH&S, and cGMP compliance. Due to involvement in the timely execution of manufacturing processes, a strong proactive attitude, organizational skills, and flexibility in working hours are required.

Other Job Requirements:

Adhere to EH&S processes and ensure a safe and healthy workplace environment. Work safely and only perform tasks if currently competent and/or authorized. Report hazardous conditions, hazardous actions, incidents, and near-miss incidents. Participate in EH&S activities (such as inspections and risk assessments) as advised.

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