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Quality - SR Quality Specialist

Company: ASAP Staffing
Location: New Brunswick
Posted on: May 1, 2021

Job Description:

Role Quality - SR Quality Specialist Location New Brunswick, NJ (Locals Only) Duration 11 months Job Description Role and Responsibilities 1. Lead, develop, and manage a robust process relating to supplier change notification. 2. Execute and improve network procedures for BMS sites globally. This may requires revisions to procedures for managerial review and approval and drafts documentation where appropriate. 3. Train on multiple proceduresprocesses, and provide support to a wider spectrum of stakeholders in the network. 4. SME in multiple aspects of documentation and supplier quality management (i.e. supplier change control, vendor management, supplier scorecard, quality agreements, approved supplier list, material qualification, reduce testing, etc.) 5. Knowledgeable of supplier change notification and change control. Primary resource for change control. 6. Lead supplier change notification metricsKPI generation and reporting. 7. Support supplier investigations and trending as needed. 8. Act as Quality lead on assigned projects. 9. Skilled in writing, reviewing supplier quality agreements and master supplier agreements Additional responsibilities include -Daily contact with herhis manager for work assignments. Routine contact with manager for coaching and general performance management discussions. -Occasional contact with other management staff relating to specific project responsibilities may be expected. -May represent Quality in cross-functional teams or projects. -Cross-sitevendor communications as needed for strategic purposes -Required to coordinate with site stakeholders for troubleshooting purposes relating to suppliers. -May be expected to lead cross-functional project team. -Expected to participate in the training of less experienced personnel as well as assisting less experienced personnel in normal operational tasks. SkillsQualifications bull Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, chemistry, supply chain, a related discipline, or the equivalent in related experience. bull 6-9 years of experience in Supplier Quality, cGMP Biologics QC laboratory or related cGLP or cGMP environment. bull Proficiency (or mastery) of methodologies within QC (i.e. reduce testing, qualification, etc.) and supplier quality (i.e. change control, investigation, non-conformances, corrective actions, agreements, etc.) bull Attention to detail and demonstrated organizational skills. bull Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints. bull Proficiency in applying cGMP regulations and cGMP processes. bull Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices. bull Demonstrates leadership, and independent problem solving and analytical thinking skills. bull Proficiency with common computer software applications (email, MS Office, etc.) and lab based computer applications LIMS, SAP, or similar, and Infinity or similar. bull Will work in teams and have continual interaction with members of hisher team as well as other sub-teams within QA in order to exchange information regarding supplier quality as it relates to meeting department goals and objectives bull Should be observant of work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions. bull Incumbents normally receive little to no instructions on routine work and assist with the creation of detailed instructions on new assignments. -Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing, laboratory, andor project timeline -Flexibility to work irregular hours and short notice overtime. Thank you, Sajitha Pedamallu,

Keywords: ASAP Staffing, New Brunswick , Quality - SR Quality Specialist, Other , New Brunswick, New Jersey

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