Supplier Quality Specialist
4 weeks ago
Job Summary
Curium Pharma is seeking a Supplier Quality Specialist to join our team. This role is responsible for supporting the Supplier Quality program to ensure compliance with applicable GMP regulations.
Key Responsibilities
- Maintain the certified supplier list
- Ensure site supplier assessments are current and up to date based on quality risk
- Comply with US and international regulatory agencies and guidelines
- Conduct supplier audits and ensure adherence to supplier schedule
- Author and own supplier change control process
- Submit SCAR deviations to suppliers for defects found
- Provide support for FDA or other regulatory agencies for on-site audits
- Serve as site Quality SME on MSD
Requirements
- Bachelor of Science in Biology, Chemistry, or related field required
- 3 or more years of relevant experience required
- Experience investigating exceptions and out of specifications preferred
- Ability to resolve problems, handle conflict, and make effective decisions under pressure
- Proficient in Microsoft suite office products and good computer skills
- Good hands-on, analytical, and problem-solving skills
- Excellent writing and verbal communication skills
- Ability to work independently and with others to accomplish goals and priorities
- High level of energy and regular, consistent attendance
- Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment
Working Conditions
Willingness to work in a plant producing radioactive materials and participate in safety programs to minimize potential and/or actual exposure levels.
Responsibilities include lifting up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, and wearing and operating safety equipment.
Must be willing to work indoors and outdoors with exposure to mechanical/moving parts, hazards, including corrosive, flammable, and toxic materials, dust, dirt, odors, and irritants.
Willingness to complete safety training within allotted timeframes and work in a team-based environment.
Must be able to work outside of regular work hours, including off-shift, weekend, and holiday work as business needs require.
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