Aerotek QA Specialist in Saint Louis, Missouri
The Quality Assurance Engineer is responsible for quality assurance activities with oversight of investigations, the Quality Management System SOP’s, validations and quality continuous improvements. This position reports into the QA Manager.
Use Quality Engineering principles, tools and techniques to develop and optimize systems and processes so that they are aligned with company strategy and regulatory requirements. Provide support for customer, regulatory and internal audits. Use root cause analysis and risk assessment tools and techniques to perform investigations and determine appropriate corrective action. Lead, coordinate and maintain validations for all departments. Lead, coordinate and maintain Calibration Program. Lead, coordinate and maintain Environmental Monitoring Program. Conduct audits (both internal and supplier) and monitor compliance with ISO and FDA Quality System Regulation standards. Collect, review, and interpret data for trend report, metrics, quality system review and complaints. Update approved supplier index as required. Review and approve quality assurance procedures and reports. Maintain SOP's and Quality Management System as directed by QA Manager.
Quality assurance, Gmp, Cgmp, Qa, Capa, Pharmaceutical, Audit, Fda
Top Skills Details:
Looking for someone with solid pharma QA experience who has exposure to validations.
Additional Skills & Qualifications:
BS Degree in Sciences or equivalent combination of experience required CQE/CQA certification preferred
Minimum 3-5 years relevant experience including one or more of the following: QA oversight of process validation and method validations Experience in deviation and complaint investigations, including root cause analysis tools and technical writing CAPA Experience conducting and supporting audits Document Control and Batch Record Issuance/Archival Batch Record Review Must be proficient in MS Office (Word, Excel, Access)
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.