QA Compliance Contractor - 1st shift

QA Compliance Contractor - 1st shift
  • Competitive
  • Temporary
  • Gaithersburg MD, US Gaithersburg Montgomery Co. US 20879
Job Ref: JO000122354
Sector: Clinical
Sub-sector: Quality
Date Added: 24 September 2021

QA Consultants

Baltimore, MD - 4-6+ Month Contract - 1st 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.


30/10/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Ryan Heavirland

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