Senior QA Officer

Work Schedule

Environmental Conditions

Job Description

About Us:

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.

Location/Division Specific Information:

This role sits within the Pharmaceutical Services Group (PSG)/ Drug Substance Division (DSD) and is based onsite in our Brisbane offices. Min 3-4 days a week in the office required.

Position Summary:

The Senior QA Officer role reports in to the Supervisor - Product Quality Team. 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 ensures compliance to the applicable cGMP requirements. This position is responsible for collaborating with operational areas and company customers to provide real time quality support and maintain site quality standards.

What You'll do:

• Disposition of drug substances and in-house manufactured final formulation buffers.
• Approve stability studies and contract release/stability testing for externally manufactured products.
• Represent the Quality team in client project meetings and follow through with client communications.
• Review and approve completed laboratory and production records.
• Perform QA review of analytical method validation, qualification, and resulting summary reports.
• Update Quality SOPs and other documents to meet current regulatory and corporate standards.
• Support Deviations Investigations to identify causal factors and root causes.
• Perform Quality Approval of completed Deviation, CAPA, OOT/OOS records, and other Quality system records in the required timeframe.
• Identify continual improvement opportunities and participate in the Practical Process Improvement system.
• Collaborate internally with Quality & Regulatory, Project Management, Operations, Material Science and Technology (MSAT), Facilities & Engineering, Warehouse, Counterparts/ peers within the Biologics /PSG network; and externally with Clients and Regulatory Agencies

Keys to success:

Education:

• Tertiary level education in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).

Knowledge Skills & Experience:

• Industry training or experience in disposition processes.
• Minimum 5 years’ indusry work experience in a (bio) pharmaceutical company or transferable skills from related fields.
• Good knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
• Excellent interpersonal skills with strong written, verbal, and presentation abilities.
• High level of attention to detail.

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 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.