<p>Work Schedule</p> <p>Standard (Mon-Fri)</p> <p>Environmental Conditions</p> <p>Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Warehouse</p> <p>Job Description</p> <p>Location/Division Specific Information</p> <p>The Thermo Fisher Scientific Swedesboro site is part of the PSG-CTD Division. It is a multi-product and multi-client biopharmaceutical site supporting Clinical Ancillary Management (CAM). We provide storage and order fulfillment of commercial and commercial-free pharmaceutical products for our clients. We have capabilities to support and store products that require cold chain and ambient processing.</p> <p>Discover Impactful Work:</p> <p>The QA Engineer, II will play a crucial role in maintaining Quality oversight within all operations of the business, while continuously looking for ways to develop and improve systems.</p> <p>A day in the Life:</p> <ul> <li>Tracks open records in TrackWise to include Deviations, Complaints, CAPAs, observations and Change Controls to closure. </li><li>Supports during client and regulatory audits and inspections, as well as with responses to findings and CAPA's as applicable. </li><li>TSA Principle Security Officer, to include collaborating with TSA personnel requesting shipping documents and TSA agent walkthroughs of the facility. </li><li>Document creation & control within electronic document system, to include making recommendations to draft documents, revising QA documents and Standard Operating Procedures (SOP's) as required. </li><li>Learning Management System, overseeing employee training curricula. </li><li>· Other duties may be assigned to meet business needs. </li><li></li></ul> <p>Keys to Success:</p> <p>Education</p> <ul> <li>Bachelor's degree is required, preferably with a technical or life sciences focus. Statistics preferable. </li></ul> <p>Experience</p> <ul> <li>Minimum of 3 years of experience in TSA (Transportation Security Administration) compliance. </li><li>Extensive knowledge and application of GMP (Good Manufacturing Practices) within pharmaceutical quality systems. </li></ul> <p>Knowledge, Skills, Abilities</p> <ul> <li>Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment. </li><li>Must have strong technical writing authorship and be able to review reports while effectively inputting and expressing Quality risk management risks. </li></ul> <p>Physical Requirements / Work Environment</p> <ul> <li>This position is administrative and is positioned in an office environment. </li><li>It requires standing bending reaching, walking and talking as well as exerting up to 20lbs. </li></ul> <p>Relocation assistance is NOT provided</p> <p>Must be legally authorized to work in the United States without sponsorship, now or in the future.</p> <p>Must be able to pass a comprehensive background check, which includes a drug screening.</p>