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Quality Assurance Analyst II

Company: YPrime
Location: Raleigh
Posted on: February 24, 2021

Job Description:

Is your career in its prime?? It could be! YPrime's Quality and Compliance team is looking for a?Quality Assurance Analyst II to help manage the quality management systems and investigations and ensure that all documentation meets all regulatory requirements and follows YPrime Standard Operating Procedures. You'll be based in our?Raleigh, NC office.At YPrime, we help our clients in the pharma and biotech industries to collect data from patients using mobile devices, assign patients to study treatment groups and dispense clinical trial drugs and supplies using web apps.? We're supporting life-altering research, one project at a time.Does our mission sound like something you can get behind?? If so, here's what we need from you:* Bachelor's degree or equivalent * Experience in a software environment* Microsoft Office experience with proficient knowledge in Excel* Demonstrated analytical skill * Demonstrated organizational skill * Excellent oral and written communication skills * Extreme sense of detail orientation * Excellent time management skills * Demonstrated ability to take initiative; self-directed * A commitment to quality * Commitment to follow-through * A positive attitude * A team-oriented spirit Have these things too? Even better! * Experience with trending and analysis on data from CAPAs and deviations* Well versed in 21 CFR Part 11* Experience writing policies and/or procedures * Exposure to and basic database knowledge (I.e. SQL Server, MySQL, MS Access), or aptitude to learn quickly Here Are Some More Details About The Job* You'll review and approve validation/verification documentation and facilitate project/product releases for all applicable environments* You'll serve as localized escalation point for low and high severity issues arising from assigned locations. You'll provide guidance and direction to key operational and delivery stakeholders in matters of compliance and best practice. You'll be responsible to escalate critical severity issues to QA management* You'll assist in the development, implementation, and maintenance of YPrime's Quality System, including facilitating process improvement activities to the product and project teams supporting continuous improvement, leading efforts in certain areas* You'll perform and participate in internal audit to ensure that Quality Standards are being adhered to* You'll act as a mentor to Quality Assurance Analyst I* You'll conduct ongoing training and support for new and existing staff on the Quality Manual and other key areas including Corporate SOPs, GCP, 21 CFR Part 11, validation, and process improvement/problem solving* You'll assist in the maintenance of the corrective/preventive action (CAPA) program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics* You'll participate in the evaluation of the quality events, incidents and possible complaints or compliments and the appropriate follow-up* You'll assist, manage, and/or maintain status tracking of internal audits and responses, sponsor audits, and vendor audits* You'll support the company during external inspections, as required* You'll support/perform vendor assessment/qualification audits, as required* You'll liaise with clients and suppliers where necessary (where impacted/affected by quality concerns)* You'll perform other duties as assignedWhat are the YPrime Perks? * Uncapped paid time off * Comprehensive benefits package largely subsidized by YPrime * 401(k) with company match * Flexible working arrangements with an emphasis on work/life balance * Friendly, smart, passionate and hard-working coworkers * Opportunities for professional growth and advancement

Keywords: YPrime, Raleigh , Quality Assurance Analyst II, Professions , Raleigh, North Carolina

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