Company : Actalent
Country: United States
Location : Palo Alto, California
Post: Sat, 11 Sep 2021 05:10:27 GMT
Expires: Mon, 11 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
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DESCRIPTION:Under the general supervision of the Technical Services Director, perform the quality assurance duties of the Technical Services department by writing/revising department equipment and process validation plans, managing equipment preventative maintenance program, manage training records, perform process and computer audits, write/revise procedures for regulatory compliance as necessary. Prepare training binders for new staff and monitor new and incumbent staff training is up to date. Ensure annual SOP and label review performed, review departmental records, help determine corrective actions for events by performing root cause analysis, and is involved in process improvement. Perform post-donation information follow-up that affects safety, purity, and quality of the product by quarantine/discard of units, notification of customers and tracking of recalls. Provide notification to hospitals, regulatory agencies and other customers of test results that affect patients/general population safety.- Write/revise/review equipment, process validation plans, and procedures, as necessary. Ensure annual review is completed for all departmental procedures (SOPs), forms and labels.- Prepare training binders and training schedule for new staff. Ensure completion of training documentation for SOPs. Ensure 6 month and annual competency is completed on time. Maintain training documentation files. Perform annual exposure control plan training for Technical Services team members.- Review department records for accuracy and ensure they meet acceptance criteria, including state and federal regulatory guidelines and internal policies. Manage equipment preventative maintenance (PM) program.- Review/discard/release blood products from quarantine based on review process. Perform hospital/customer/county and state notification of infectious disease exposure.- Perform audits of laboratory and computer processes to verify staff performs tasks per procedure.- Perform root cause analysis for events and determine corrective action, monitor trends, and initiate process improvement as needed. Ensure timely completion of event reporting, quality indicators, and corrective action plans as required by regulatory entities.- Act as member of Safety Committee and perform inspections of the department to ensure Health and Safety compliance.- Act as inspection coordinator for the department during internal and external inspections.EDUCATION & EXPERIENCE:Bachelors degree in a related field. Minimum 1 years experience in GMP environment required.KNOWLEDGE, SKILLS AND ABILITIES: Demonstrated ability to train staff. Quantitative and qualitative data analysis skills. Basic understanding of current Good Manufacturing Practices (cGMP) and application in work setting. Demonstrated organizational skills and detail orientation and ability to manage competing priorities. Ability to effectively communicate orally and in writing with diverse audiences; ability explain technical concepts clearly and concisely. Ability to maintain appropriate current knowledge of and interpret specific government agency requirements (statutes, regulations, licenses, and permits). Ability to work independently and with minimal supervision. 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. Were 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.
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