Baltimore, MD - 4-6+ Month Contract - 2nd Shift
Our client in Baltimore, MD is ramping up and we are looking to place a team of consultants on site. The FDA hit them hard with observations and they are needing at least 9 consultants (3 for each shift) with QA Shop floor Compliance experience. There are more than 1000 deviations/CAPA’s that need to be remediated.
Key Duties will include:
• Author, review and approve Material Specifications
• Assist with Harmonization of Material Specifications across multiple site operations for support of a centralized warehouse
• Act as a QA approver for Quality Master Data for materials in ERP system
• Perform receipt inspection and critical reviews of Material documentation submitted for QA disposition by exercising judgment within defined procedures and regulations
• Author, review and approve Standard Operating Procedures as it pertains to Material Disposition and Material Specifications
• Write deviations and provide support of CAPAs and Change Controls as it pertains to the disposition of Materials and Material Specifications.
• Track and trend raw material release data for monthly Quality metrics.
• Respond to various interdepartmental requests. Answer questions and provide feedback to ensure Quality and departmental objectives are met.
• Keep management informed of concerns/issues/successes
• Within area of responsibility, understand and comply with all safety and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs
• Identify and lead opportunities for process improvements within scope of work
• Participate in Lean Six Sigma activities
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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