Quality Assurance Engineer careers in Actalent Maryland Heights, MO
This Jobsfunter Listing is about Actalent in Maryland Heights, MO 2022
About the job
- Description:* The Quality Assurance Engineer will be working on a cross functional project with R&D, Engineering, and Quality to increase capacity for an existing product.
Will document R&D progress and work with others to develop and implement batch records and SOP’s to maintain compliance to FDA guidelines. Will analyze data and work within Excel and other systems to maintain data integrity principles. Will observe manufacturing processes and participate in feasibility runs to support project objectives.
Will write and develop technical materials, procedures, records, etc. Primary Quality Operations contact to ensure quality compliance for manufactured products. Investigates or approves exceptions / out of specifications with root cause analysis tools to ensure appropriate corrective actions are identified to reduce / prevent recurrence.
Supports or initiates continuous quality improvement activities. Review and approve Change Control/Quality Documents involving product or process changes. Review and approve validations (equipment, cleaning and/or process) for assigned area. Prepares and participates in regulatory agency (i.e. FDA, etc.) audits as well as internal audits. QA contact for risk management activities, including FMEA’s (Failure Modes and Effects Analysis). Investigate or serves as QA approver for customer complaints, exceptions / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce
/ prevent recurrence, within required timeframes and documented in the sites EQMS (Electronic Quality Management System). Assemble, analyze and report QA data to ensure regulatory compliance, identify trends and to identify areas of improvement. Develop, review and/or revise SOP (standard Operating Procedures), BR’s (Batch Records), STM (Standard Test Methods), Specifications, FMEA’s.
- Skills:* root cause analysis, gmp, capa, quality assurance, compliance, engineering, life science, investigation and analysis
- Additional Skills & Qualifications:* Bachelor Degree in Life Sciences or Engineering. Minimum 3+ years of Quality experience in a pharmaceutical manufacturing environment or technical writing experience in any capacity in an FDA regulated environment. Knowledge of deviations, investigations, CAPA’s, and associated updating of documents to address CAPA’s and routing through change control. Working knowledge of cGMP guidelines and their application in a controlled aseptic environment is strongly preferred.
- Experience Level:* Expert Level
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.
Vacancy Type: Contract · Entry level
Job Location: Maryland Heights, MO
Application Deadline: N/A