QA Officer

at  Thermo Fisher Scientific

ABOUT US

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer! Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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 QA Officer will join our outstanding Quality-on-the-floor program and assist operational areas with real time quality support.

Skills and Requirements:

• Tertiary Academic level in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).
• Minimum 3 years of experience in a GMP regulated environment.
• Preferably, minimum 1 year of experience in Quality Assurance in a GMP regulated environment.
• Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
• 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.
• Not knowingly pollute the environment

• Drive compliance to Quality Management System, by performing batch record reviews - reviewing protocols during the manufacturing process as well as post-production to ensure the quality of the product.
• Performing routine audits of logbooks used in the operations/QC areas for completeness and cGMP compliance.
• Performing final QA review and approval of batch related documentation
• 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.
• QA Approval of quality records including but not limited to; Deviations, Out Of Specifications, CAPAs, 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 as required to other departments.
• Perform quality functions including vial thaw, drug substance shipping as required
• 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.
• Identification of continual improvement opportunities Conducting Internal Audits
• 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).
• Minimum 3 years of experience in a GMP regulated environment.
• Preferably, minimum 1 year of experience in Quality Assurance in a GMP regulated environment.
• Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
• 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.
• Not knowingly pollute the environment.

We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. If you are a motivated individual with a passion for demand planning and inventory management, we invite you to apply for this exciting opportunity. Watch as our colleagues explain 5 reasons to work with us.
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