Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. 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 Equipment Validation (potentially also Process 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.
- Ability to work independently and collaborate effectively with cross-functional teams
- Ability to prioritize and adapt in a changing environment
- Any other legitimate duties requested by QA Manager.
REQUIREMENTS:
- 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.
Benefits
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 125,000+ 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.
