
Product Support Specialist
2 days ago
This is a critical role that requires technical expertise and leadership skills to support the Product Quality organization. As a product support specialist in Quality, you will work with various groups on projects, including product specifications, in-process controls, and complaint resolutions.
Key Responsibilities- Provide technical support to the Product Quality Team (PQT) for late-stage and/or commercial biologic or synthetic programs.
- Evaluate complex process and product quality data, such as in-process, release, and stability data, complaints, and method performance.
- Author and review GMP and regulatory documents, and execute transactions in relevant GMP systems.
- Collaborate with Quality Control, Regulatory, Process Development, and other groups on projects.
- A Doctorate degree with two years of experience, a Master's degree with six years of experience, or a Bachelor's degree with eight years of experience in Chemistry, Biochemistry, Biology, or a related pharmaceutical sciences field.
- Experience in Quality, Operations, Scientific, or Manufacturing.
- Strong scientific data management and organization skills with attention to detail.
- Expertise in computer applications such as Veeva, Spotfire, SHINY, and MS Office.
- Opportunity to be at the interface between research, global development, and manufacturing to ensure molecules become medicines.
- Chance to build and maintain multi-functional relationships and strong partnerships through effective communication.
- Contribute to Product Quality initiatives intended to ensure overall product health.
- Proficiency in oral and written communication of complex information to team members and peers.
- Analytical and problem-solving skills to evaluate complex process and product data.
- High degree of initiative and self-motivation, with the ability to manage multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals and the ability to work effectively with global, virtual teams across multiple time zones.
Technical Skills
- Demonstrated proficiency in cGMP and international regulatory expectations.
- Strong analytical and problem-solving skills.
- Expertise in computer-based GMP Quality systems.
- Proficiency in MS Office.
Soft Skills
- Effective communication and presentation skills.
- Ability to work in a fast-paced environment.
- Collaborative mindset and willingness to learn.
- Results-driven individual with a passion for delivering high-quality results.
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