We're seeking a proactive Quality Specialist to join an Integrated Product Team, providing dedicated QA support to a specific production area. Working with guidance from Quality leadership, you'll be instrumental in ensuring the quality and regulatory adherence of manufactured products. This role involves being a visible quality representative on the shop floor, fostering a culture of compliance and best practices.
Your key responsibilities will include: meticulous review and approval of production documentation (Master & Electronic Batch Records, logbooks), providing real-time QA presence and guidance on the shop floor, supporting commissioning and qualification activities, and contributing to continuous improvement initiatives. You may also be involved in batch disposition and deviation support.
This is a shift role with a desirable 4 on/4 off schedule (4 x 12hr extended days followed by 4 days off).
To thrive in this role, you'll need:
- Minimum 5 years of relevant post-degree experience in GMP Manufacturing, Quality Assurance, or a Laboratory environment within the Pharmaceutical/Biological sector.
- A strong working knowledge of biotech QA operations and regulatory agency engagement.
- Demonstrated leadership skills and excellent oral and written communication abilities.
- A thorough understanding of cGMPs and relevant pharmaceutical regulatory requirements.
- Strong interpersonal skills, including flexibility, collaboration, and the ability to work effectively in a team.
Preferred experience includes: working with quality systems, pharmaceutical manufacturing or laboratory processes, GMP document authoring/approval, analytical and problem-solving skills, experience coaching others, and familiarity with shop floor operations and GMP documentation review. A Bachelor's degree in a scientific or engineering field is preferred.
