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QC Raw Materials Supervisor - Biologics

Company: Grimaldi Staffing Services
Location: Newark
Posted on: February 25, 2021

Job Description:

General DescriptionThe QC Raw Material Supervisor will be responsible for improvement, development, implementation and maintenance of the raw material program and internal procedures and processes in compliance with regulatory requirements and commitments for clinical and commercial products. The individual will work closely with a cross-functional team (e.g. Manufacturing, Quality Assurance, Supply Chain, etc.) and external laboratories to ensure testing completion and review and approve the results.Responsibilities* Maintain raw material program in compliance with regulatory requirements and commitments for clinical and commercial products. * Work in a cross-functional team to ensure raw material disposition in a timely manner for the continued support of manufacturing operations.* Maintain existing and perform qualification of new raw material suppliers including documentation in accordance with internal procedures.* Manage contract testing laboratories for testing of raw materials within turnaround times to ensure on time disposition of materials* Review and approve raw material results; report, manage and investigate non-conforming and out-of-specification results in timely manner to ensure appropriate immediate actions are taken.* Ensure raw material equipment and sampling facilities are appropriately validated, calibrated and maintained. * Perform raw material sampling including QA retains and testing to internal specifications.* Manage development and validation of non-compendial test methods for raw material release, as needed* Will supervise and guide raw material coordinatorEDUCATIONMinimum Required:* BS in Biochemistry, Chemistry or related Sciences* 5+ years in a GMP environment (pharmaceutical or biotechnology industry) with at least 2 of those years in a QC senior analyst role supporting raw material programQualificationsMinimum Required:* Proven strong interpersonal, organization and problem-solving skills* Solid knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to raw materials* Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environmentPreferred:* Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines* Experience with preparing regulatory documentation and inspection managementPowered by JazzHR1VvGxNaU31

Keywords: Grimaldi Staffing Services, Newark , QC Raw Materials Supervisor - Biologics, Other , Newark, California

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