Quality Associate II JR-172299 Position Available In Marshall, Mississippi

This is a Job Description for a Quality Associate II in Byhalia, Mississippi.

Summary:

The Quality Associate II is responsible for providing Quality support to the Global Logistics Center. Inspects products, initiates and updates procedures, reviews temperature monitoring data, and ensures compliance with GMP/QSRs requirements, according to corporate and local Standard Operating Procedures, and all applicable FDA and state regulations.

Duties & Responsibilities•:•[]{#_Hlk142289191}[]{#_Hlk142304825}Leads ongoing, daily departmental operations of medical devices and drug products local and global distribution. Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Work closely with supervisors, Quality, Operations and other internal groups to accomplish the above and influence vital actions. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans. Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other Quality areas in the successful performance of these activities. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items. Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead. Other duties, tasks or projects as assigned. Sustain a clean and safe work area using 6S principles Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).

Requirements and Qualifications:

BS in business/science or equivalent. 3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry. ASQ Certified Quality Auditor, or other Quality certification, is preferred. Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to encourage teamwork and drive decisions. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, and application of Good Manufacturing Practices. Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings. Must have basic English written and oral communication skills adequate to communicate with other team members. Equal Opportunity/Affirmative Action Employer.