Associate QA Officer

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

Job Description

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 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.

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.

• 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.

Apply today! http://jobs.thermofisher.com

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.