Are you passionate about ensuring the highest standards of quality and compliance in pharmaceutical manufacturing? Breathe Life Sciences is seeking a talented Senior QA/QC Associate to join our pioneering team in revolutionizing the landscape of psychedelic and medicinal plant-based therapies. As the first manufacturer in Australia licensed by the Therapeutic Goods Administration (TGA) to manufacture MDMA, Psilocybin, and Medicinal Cannabis, we are dedicated to delivering safe, effective, and innovative treatments to improve lives worldwide.
**About Breathe Life Sciences:**
Breathe Life Sciences is at the forefront of pharmaceutical innovation, harnessing the therapeutic potential of psychedelic compounds and medicinal plants to address unmet medical needs. With a commitment to rigorous scientific research, regulatory compliance, and compassionate care, we are shaping the future of mental health and wellness.
**Position Overview:**
As a Senior QA/QC Associate at Breathe Life Sciences, you will play a crucial role in maintaining the highest standards of quality assurance and quality control across our manufacturing operations. Working closely with cross-functional teams, you will ensure compliance with regulatory requirements, industry standards, and company policies to uphold the integrity and safety of our products.
**Key Responsibilities:**
- Develop and implement quality assurance and quality control procedures to support the manufacturing of MDMA, Psilocybin, and cannabis products.
- Conduct risk assessments and identify areas for process improvement to enhance product quality, efficiency, and regulatory compliance.
- Perform batch record review, deviation investigation, and root cause analysis to identify and resolve quality issues in a timely manner.
- Collaborate with manufacturing, research and development, and regulatory affairs teams to support product development, scale-up, and commercialization activities.
- Lead internal and external audits, inspections, and quality management system reviews to ensure compliance with TGA regulations, Good Manufacturing Practices (GMP), and other relevant standards.
- Provide training and guidance to team members on quality systems, regulatory requirements, and best practices for quality assurance and quality control.
**Qualifications:**
- Bachelor's degree in Chemistry, Pharmacy, Biochemistry, or related field; advanced degree preferred.
- Minimum of 5 years of experience in quality assurance and quality control roles within the pharmaceutical, biotechnology, or related industry.
- Strong knowledge of TGA regulations, GMP guidelines, and international quality standards (e.g., ICH, USP, EP).
- Experience in conducting internal and external audits, inspections, and regulatory submissions.
- Excellent communication, problem-solving, and decision-making skills.
- Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams.
**Benefits:**
- Competitive salary and benefits package
- Opportunity to be at the forefront of a rapidly growing industry
- Collaborative and innovative work environment
- Professional development and growth opportunities
**Join Our Team:**
If you are passionate about quality, compliance, and making a positive impact in the lives of patients, we invite you to join us in our mission at Breathe Life Sciences. Together, we can pave the way for a healthier, happier future through the power of psychedelic and medicinal plant-based therapies.
To apply, please submit your resume and cover letter outlining your qualifications and interest in the position. We look forward to welcoming you to our team!
Job Type: Full-time
Pay: $90,000.00 – $100,000.00 per year
Schedule:
8 hour shift Work Location: In person
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