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Senior QA Associate

Company: Aerotek
Location: Miami
Posted on: April 10, 2021

Job Description:

Description:Duties & Responsibilities: include but are not limited to:Product quality assurance & batch dispositionProviding QA oversight of the supply chain organization, internal manufacturing, partnerships associated with overall product manufacture, labeling, packaging, shipping, warehousing, and distribution of product.Coordinate disposition activities for products with internal and external (client) partners.Write, revise or review SOPs, specifications and other GMP documentationInteraction with both internal and external client personnel to ensure cGMP compliance and continuous improvementProvide quality support and approval of process development, verification and validation strategies, plans, activities, protocols, reports, etc.Assess and investigate deviations. Review and approve formal investigations. Identify and ensure timely completion of CAPAs.Provide quality oversight and review of change control requests and management.Support the review of technical product complaints.Provide support for technology transfer activities, regulatory inspections, audits, and validation/qualification activities (equipment / shipping etc.) at contract manufacturing partner sites.Analyze and trend in-process data related to manufacturing of products.Conduct periodic site audit visits as required. Author/Review regulatory filings for clinical and/or commercial products. Author/Review Standard Operating Procedures (SOPs), work instructions, specifications, and other GMP documentation.Author/Review relevant annual product review reports (APRs).Coordinate with manufacturing, QC, suppliers and product development teams on project matters, material issues, process capability studies, and product quality issues for existing processes, products and related projects, as required.Develop/Support Vendor Qualification program by working with cross functional teams to perform qualification audits and vendor monitoring and maintenance activities. Support the development and implementation of Vendor Corrective Action program to help manage complaints and remediation activities at vendors.Support the development and implementation of Vendor Change Management program to help manage and review notifications of changes sent to by vendors.Support the Internal Auditing Program when required.Assist in Regulatory Inspection Readiness and Inspection Management efforts. About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Miami , Senior QA Associate, Other , Miami, Florida

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