Product Safety Expert Job

PRODUCT SAFETY EXPERT needed for a CONTRACT opportunity with Yoh's client located in MELVILLE, NY.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Quality
- cGMP

WHAT YOU'LL BE DOING:

- Support maintenance of the oversight of the assigned products and related processes at the Site (eg from raw materials to primary packaging and applicators as appropriate).
- Support all process and filling/packaging validation activities and weak point product remediation projects.
- Support preparation and maintenance of product specific Quality Risk Analyses (QRAs)
- Use scientific and statistical knowledge to analyze data to provide product understanding, and identify root causes of product and process failures.
- Track CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Critical Quality Attributes CQA, Critical Material Attributes CMA, etc.) using statistical analysis and conducting regular product specific data trending.
- Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.
- Provide Quality Risk Assessment (QRA) documentation with Control Strategy prior to Validation.
- Adhere to all applicable procedures, cGMPs, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
- Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
- Provide oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content
- Participate and/or lead (case by case) the change controls to its products and related processes.
- Provide support for process capability assessment.
- Own the Training Curriculum for its Job Profile and provide the necessary training and support to new associates joining the Product Expert position and this position.
- Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit.

WHAT YOU NEED TO BRING TO THE TABLE:

- B.S. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or Chemical Engineering.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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