Quality Control Scientist I (Raw Materials)
Catalent Pharma Solutions in Kansas City, MO is hiring a Quality Control Scientist I for the Raw Materials Department. Under supervision and guidance, performs tasks from detailed instructions and established procedures. Comply with site SXPs, corporate policies, and Environmental Health and Safety requirements. Has advanced knowledge of the principles, theories, and concepts applicable to a wide range of work in a discipline and broad knowledge of principles and concepts in other disciplines. Applies technical and functional knowledge to assist in experiment/project design that will enable the department/team to meet goals. A self-motivated, detail-oriented person who is able to make decisions and solve problems is essential. Able to work independently with little to no supervision, and flexible to also assist team members as needed.
This is a full-time role position, Monday- Friday, Days
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Being a Catalent Associate offers you countless opportunities to have direct impact on the health and well-being of millions of people globally! Your passion for learning coupled with Catalent’s superior technologies will help drive the advancement of medicine in collaboration with leading pharmaceutical, biotech and health care innovators.
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role
- Execute testing procedures for the identification and characterization of raw materials per USP, EP, and JP. Techniques include, but not limited to: HPLC, GC, UV/Vis, FTIR, conductivity, and wet chemistry.
- Develop and execute laboratory work plans/ schedules independently using customer milestones and department/team performance standards and metrics. May direct work of technical staff, including work assignments.
- Maintain high quality documentation in accordance with applicable regulatory guidance and site SOPs documenting work as appropriate within notebooks, forms, etc.
- Execute procedures or methods of moderate and advanced complexity with high quality and reviews own work to ensure accuracy and completeness. Able to identify larger quality/compliance gaps within the lab and remediate with guidance.
- May develop/validate methods of moderate and advanced complexity.
- Author technical documents such as protocols, methods, text reports, SXPs, specifications, and/or certificates of analysis. Manages investigations with guidance. May participate in or draft events or deviations.
- Perform peer review of routine and complex laboratory documentation. Review technical documents for accuracy, thoroughness, and regulatory compliance.
- Responsible for assigned project outcome and customer interaction.
- Execute efficiency/compliance improvement projects with guidance. Identify and recommend business opportunities on a project specific basis.
- All other duties as assigned
The Candidate
- Requires a Bachelor's degree in related life science or physical science field with 6+ years related work experience; OR a Master’s degree in related life science or physical science field with 4+ years related work experience; OR a Doctorate Degree in related life science or physical science field with 0+ years related work experience
- Strongly prefer GMP experience
- Excellent written and verbal communications skills with internal and external customers
- Well organized with ability to multitask and have the ability to work effectively under pressure to meet deadlines
- May require the use of a respirator
- Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds
Why you should join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- 19 days of PTO + 8 paid holidays
- Dynamic, fast-paced work environment
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive salary with quarterly bonus potential
- Community engagement and green initiatives
- Generous 401K match and Paid Time Off accrual
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
- GymPass program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories