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Quality Assurance Engineer

Company: Actalent
Location: Deerfield Beach
Posted on: September 21, 2022

Job Description:

Description:QA Engineer provides oversight of GMP operations to ensure that products are manufactured according to cGMP requirements and fit for their intended use. Maintains data collected from the manufacturing process, generates, and updates procedures and ensures Batch Records comply with established policies and procedures.List of Responsibilities:--- Review and Approve Production Batch Records and Testing Results to ensure they are complete, accurate and documented according to established procedures.--- Prepare CofC and CoAs --- Maintains QA manufacturing floor presence in support of manufacturing operations and provides oversight over process related decisions.--- Reviews and approves Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions and Test Methods.--- Provides oversight to Risk Management programs, procedures, and documentation for Development and Process Validation activities.--- Review and approve Qualification packages (User Requirements, Validation Plan, Protocols, Reports) for Facilities, Utilities, and Equipment qualification activities.--- Review and approve Test Method Development, Validation and Stability Studies protocols and reports in support of the Analytical Sciences department.--- Support the investigation process for Non-Conformances and ensures completion of related corrective and preventive actions.--- Support the Audit Team with during external and internal audits.--- Provides support to the program management office with the review and approval of the design transfer package documentation.--- Provides Quality support for throughout the product lifecycle to include the review and approval of Annual product reviews, Product Process Monitoring activities and Continuous Improvement initiatives.Skills & Qualifications:MUST:--- Preferred BS in Engineering, Biology or other technical related degree.--- 3+ years of experience in Quality with Pharmaceutical and/or Medical Device based GMP manufacturing operations.--- Knowledge of regulations and practices pertaining to pharmaceutical/medical device products and agencies FDA, EMA, JP and other regulations. --- Knowledge of Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP) and Batch Records ReviewPREFERRED:--- Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.--- Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations.--- Able to communicate effectively and work within cross-functional teams. --- Excellent oral and written communication skills with strong technical writing experience required. --- Experience in internal / external audits, identify findings, drive resolution and provide closure report About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. 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: Actalent, Deerfield Beach , Quality Assurance Engineer, Engineering , Deerfield Beach, Florida

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