Address Job Description
At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
As an employee at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
Job Title: Quality Assurance Officer
Reports to: Supervisor, Quality Systems
Position Summary:
The Brisbane site is a multi-product biopharmaceutical site with development and manufacturing facilities for biopharmaceutical products for clinical trials (Phase I, II and III) as well as commercial products. Manufacturing of biopharmaceutical products is required to be in compliance with regulatory requirements as defined by TGA, FDA, EMEA, ICH and other applicable regulatory agencies. The Quality Assurance group is responsible for ensuring compliance to the applicable cGMP requirements.
This candidate will join our Quality Assurance Team and assist the operational areas with real time quality support. If this sounds like you, we'd love to hear from you!
Key Responsibilities:
Drive compliance to the Quality Management System by:
- Performing routine audits of logbooks used in the operations/QC areas for completeness and cGMP compliance. Active participant in deviation investigations QA Approval of quality records including but not limited to; Deviations, Out Of Specifications, CAPAs, Audit findings, Change Controls, etc.
- Review and approval of QA controlled documents within the Quality Management System.
- Supports compliance to systems timeframes for raising, processing or performing associated tasks (i.e. Change Control actions, DR investigations, processing CAPAs) Issuing protocols as required to other departments.
- Updating SOP's and other documents to meet current regulatory and corporate standards Identification of continual improvement opportunities
- Participating in Risk Assessments Any other legitimate duties requested by Quality Systems Supervisor.
Frequent Contacts:
- Internal: Operations (USP, DSP, MBP) Warehouse, Validation, Engineering, Process Engineering, Quality Control
- External: Clients and Regulatory Agencies
Minimum Requirements/Qualifications:
Qualifications & Experience
- Tertiary Academic level in a relevant discipline (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).
- Minimum 2 years of experience in a GMP regulated environment
- Preferably, minimum 1 year of experience in Quality Assurance in a GMP regulated environment
Skills & Attributes
- Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
- Strong communication skills
- Strong written, verbal and presentation skills
Other Job Requirements:
- Adhere to EHS policies and procedures and ensure a safe and healthy workplace environment
- Ensure hazardous conditions, hazardous actions, incidents and near-miss incidents are reported.
- Not knowingly pollute the environment
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation and support patients in need.
Thermo Fisher Scientific 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.
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.
