Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, every one of our 75,000 unusual minds has a distinct story to share. Join us and contribute to our outstanding mission-empowering our customers to make the world healthier, cleaner, and safer. Job Title: Quality Assurance Officer Reports to: Supervisor, Quality Systems Group / Division: Pharmaceutical Services Group (PSG)/ Drug Substance Division (DSD or equivalent experience) Career Band: 4 Job Family: Operations (OPS) Job Sub Family: Quality Assurance (QAOP) Job Code: OPS.QAOP.P04 Job Track: Professional Position Location: Brisbane, Australia Position Summary: Brisbane site develops & manufactures biopharmaceutical products for clinical trials and commercial use. This candidate will join our outstanding Quality systems team and assist the Validation and Engineering team with quality support. If this sounds like you, we'd love to hear from you! Key Responsibilities: Reviewing and approving Process Validation / Equipment Validation documents promptly, including Microbial Mapping validation protocols, resin re-use protocols, cleaning validation protocols, new equipment, etc. Active participant in deviation investigations. QA Approval of quality records including but not limited to; Deviations, CAPAs, Audit findings etc. Reviewing and endorsing 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 SOPs and other documents to meet current regulatory and corporate standards. Serving as a resource to the operational areas on quality-related issues. Identification of continual improvement opportunities. Participating in Risk Assessments. Any other legitimate duties requested by QA Manager. Frequent Contacts: Internal: Validation, Engineering, Process Engineering External: Clients and Regulatory Agencies Minimum Requirements/Qualifications: Qualifications & Experience Tertiary Academic level in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent). At least 3 years of experience in a GMP regulated setting. Ideally, at least 1 year of experience in Quality Assurance within a GMP-regulated setting is preferred. 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. 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.
