About the Role
An opportunity is available for a Quality Specialist to join an aseptic pharmaceutical production facility. In this role, you will help ensure that materials, processes, and finished products meet strict quality and regulatory standards.
Your responsibilities will centre on reviewing and approving documentation, supporting manufacturing operations, and maintaining compliance across quality systems. You will play a key role in safeguarding product integrity and supporting continuous improvement within the plant.
This position operates on a second-shift schedule (afternoon to late evening, Tuesday through Saturday).
Key Responsibilities
- Oversee shop-floor quality initiatives, including maintaining procedures, tracking quality trends, and reporting findings to leadership
- Review and approve documentation related to raw materials, batch records (both paper and electronic), and production activities
- Manage the receipt, release, and investigation of raw materials and bulk containers, ensuring timely resolution of any discrepancies
- Support manufacturing operations through activities such as batch record handling, sample coordination, and label control
- Provide backup support for stability programmes, including monitoring sample testing and coordinating updates with global teams
- Maintain and approve quality-related procedures and documentation across the facility
- Develop and deliver training materials related to quality processes
- Lead or contribute to investigations, corrective actions, and preventive measures
- Review and approve change controls to ensure compliance with established standards
- Approve packaging artwork and specifications using designated systems
- Lead or participate in quality improvement projects and communicate progress to site leadership
- Investigate inventory discrepancies within enterprise systems and collaborate with relevant teams to resolve issues
- Act as a subject matter expert during internal and external audits
Your Profile
- Bachelor’s degree in a scientific, engineering, or related technical field
- At least 2 years of experience in a quality or manufacturing environment
- Familiarity with aseptic manufacturing processes such as filling, inspection, and packaging
- Strong understanding of regulatory requirements and Good Manufacturing Practices (GMP)
- Ability to collaborate across departments and influence stakeholders
- Strong organisational skills and ability to manage multiple priorities
- Detail-oriented with solid analytical and problem-solving capabilities
- Effective written and verbal communication skills
- Proficiency in standard office software tools
Working Environment & Requirements
- Work is performed in a controlled production environment requiring protective clothing and strict hygiene protocols
- Restrictions may apply to personal items such as jewellery, cosmetics, or contact lenses while on the production floor
- Exposure to varying conditions, including temperature-controlled or high-noise areas
- Flexibility to work different shifts, weekends, or extended hours when needed
- Ability to spend significant time on the production floor
- Must not have sensitivities to certain pharmaceutical compounds used on-site
- Occasional travel for training or collaboration may be required (up to approximately 25% initially)
- Role requires physical activity such as standing, walking, and handling materials up to moderate weight
What We Offer
- Competitive salary, typically within the range of approximately $71,800.00 - $112,860.00 annually, depending on experience and qualifications
- Performance-related incentives where applicable
- Comprehensive benefits package including healthcare, retirement plans, paid time off, and professional development opportunities
- A collaborative and inclusive working environment focused on innovation and continuous improvement
Equal Opportunity
We are committed to providing equal employment opportunities and fostering a diverse and inclusive workplace. All qualified applicants will be considered without regard to protected characteristics.
