Biologics Manufacturing Process Specialist

3 weeks ago

Brisbane, Queensland, Australia ThermoFisher Scientific Full time
Job Title: MBP Admin Support

The MBP Admin Support plays a crucial role in ensuring the smooth operation of our manufacturing processes. As a key member of our team, you will be responsible for reviewing critical quality documentation, identifying and addressing compliance-related issues, and providing a strong pathway for improvement.

Key Responsibilities:
  • Work closely with the MBP team to close production tasks daily, ensuring accurate reconciliation and adjustment of raw material, waste, and finished goods inventory.
  • Collaborate with production schedules to ensure timely arrival of all material requirements from external warehouses.
  • Perform root cause investigations on material stock discrepancies to identify and implement corrective actions.
  • Review expiring materials reports to mitigate stock shortfalls and material write-offs.
  • Deliver sustained improvement in site key performance indicators, including 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.
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 Smart Sheets desirable
  • Experience with Power BI Reporting desirable
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 has to 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, strong proactive attitude, organizational skills, and flexibility in working hours are required.

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.

Apply today. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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