Quality Systems Specialist

Company: Actalent
Location: Camarillo
Posted on: March 16, 2023

Job Description:

Quality System Specialist Camarillo, CA $30+Minimum 3-5 years in pharmaceutical operations required. Bachelor's degree preferred. Internal auditing experience a plus.Summary: Under the direction of the Manager of Quality Systems, the Quality System Specialist ensures compliance with Quality System requirements. The Quality System Specialist works collaboratively with personnel from other functional areas, such as, Packaging, Compliance, Procurement, Business Development, and Sales, in providing leadership for the development, maintenance, and continuous improvement of Quality System program and processes throughout GSMS. This includes, but is not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, CAPA Program, which includes the Deviation, Corrective Action and Preventive Action (CAPA).General Duties and Responsibilities:Responsibilities may include the following and other duties may be assigned. --- Leads the development, maintenance and continuous improvement of quality programs, processes and procedures. --- Responsible for interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. --- Ensures Quality System policies, procedures and performance conform to regulatory requirements, standards, and guidelines.--- Owns and leads quality system processes performance and improvements; including, but not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, Deviation reporting and investigations, Corrective Action and Preventive Action (CAPA)--- Works directly with internal and external suppliers and customers to ensure quality system requirements are met. --- Performs internal audits and inspections, including writing of audit report and presenting to upper management. Responsible for adherence to audit timelines and reporting. --- Assists with external audits of suppliers as needed. --- Responsible for managing customer and regulatory audits and inspections, including audit/inspection response and tracking.--- Leads recall related activities for customer communication, product returns and FDA reporting.--- Prepares and presents quality system performance reports to senior management.Equipment: Standard office equipment, computers, etc. Gowning for production full-body suit, goggles, cap, booties, gloves, and respirator. Physical/Cognitive Requirements: --- Strong working knowledge of FDA GMP regulations and quality system regulations/requirements --- Knowledge of manufacturing processes. --- Good communication skills at all levels, both written and verbal; both individually and in a group setting.--- Strong skills in analytical thinking and problem solving.--- Ability to perform multiple tasks and ability to effectively manage conflict. --- Ability to lead and work in teams to obtain results.--- Proactively identify issues and take action. --- Good decision making skills. Ability to make decisions with limited information.--- Effectively manage change and comfortable changing direction and acting without complete information. --- Good organizational and prioritization skills. --- May be required to work longer than the typical 8-hour work day. --- Sedentary position that may requires pro-longed long periods of desk work. --- Requires light physical duties in keeping work areas clean and organized. Regularly required to walk the production and warehouse areas.Computer Skills: --- Required working knowledge of basic Microsoft Office applications. Some knowledge of data analysis software and reporting (e.g., Excel, etc.). Attitude: --- Must be enthusiastic, concerned with job and company as a whole, openness with management, and punctual. --- Self-discipline and a desire to achieve results. --- Must be flexible and willing to change.--- Must be detail-oriented. --- Team player, professional, and achieve high quality results.Skills:QA, Quality Systems, eQMS, validation, mdr, ncr, quality, 21 cfr, root cause analysis, RCA, corrective action, project management, quality management system, audit, inspection management, capa, equipment validation, iq, oq, pq, iopq, pill counter, filling machine, labeling machine, autoclave validation, iso13485, change controls 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, Camarillo , Quality Systems Specialist, Other , Camarillo, California