Quality Assurance Specialist
1 month ago
Yoh is seeking a Quality Specialist to support our Pharmaceutical client in Noblesville, Indiana. This role is responsible for ensuring compliance with GMP regulations and maintaining the certified supplier list.
Key Responsibilities- Maintain the certified supplier list and ensure site supplier assessments are current and up-to-date.
- Ensure operational compliance with US and international regulatory agencies and guidelines.
- Serve as site auditor for suppliers 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.
- Bachelor of Science in Biology, Chemistry, or related field required.
- 3 or more years of relevant pharmaceutical industry experience required.
- Supplier Quality experience, including vendor evaluations, questionnaires, and risk evaluations.
- Experience investigating exceptions and out-of-specifications preferred.
- Strong analytical, problem-solving, and decision-making 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.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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