Associate QA Officer

3 weeks ago

Brisbane, Australia Thermo Fisher Scientific Full time

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Warehouse

**About us**

**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 applicable to cGMP requirements. The role of Associate QA Officer is an early careers role and will join our outstanding Quality-on-the-floor program and assist operational areas with real time quality support.

**Key Responsibilities**:

- Performing routine audits of logbooks used in the operations/QC areas for completeness and cGMP compliance.
- Active participant in deviation investigations - Process Validation / Equipment Validation documents for example Microbial Mapping validation protocols, resin re-use protocols, cleaning validation protocols, new equipment, etc.
- Ownership of quality records including but not limited to; Minor deviations, CAPAs, Change control Action items, Audit findings 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 to other departments.
- Perform quality functions including vial thaw, drug substance shippingred
- Updating SOP’s and other documents to meet current regulatory and corporate standards
- Serving as a resource to the operational areas on quality related issues and providing quality support on the floor
- Identification of continual improvement opportunities
- Participating in Risk Assessments
- Any other legitimate duties requested by QA Manager

**Skills and Requirements**:

- Tertiary Academic level in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).
- Experience in a GMP regulated environment is preferable
- Some knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
- An understanding QA processes is preferable
- Strong communication skills - both written and verbal
- 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.
- ** Health & Wellbeing**: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
- ** Flexibility**: Balance your work and personal life with flexible arrangements.
- ** Extra Leave**: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
- ** Charitable Giving & Volunteering**: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
- ** Learning & Development**: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

**Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality**

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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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