Quality Records Specialist

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".Job Title: Quality Records SpecialistLocation: Summit, NJDuration: 12 monthsPay rate: $34.45/ hr on W2Job Description:This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.Required Competencies:Knowledge, Skills, and Abilities:Experience with deviation and change control management, preferably with Infinity systems.Strong organizational skills, including ability to follow assignments through to completion.Ability to work in a fast paced environment, meet deadlines, and prioritize work from multiple projects.Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams.Detail oriented with demonstrated application in problem solving.With moderate oversight from manager, think strategically and understand global impact of decisions.Desired competencies:Knowledge, Skills, and Abilities:Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.Experience within the Cellular Therapeutics and/or gene-based products. Experience with biologics will be considered.Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management.Knowledge of applicable FDA/EMA regulations in the biotechnology industry.Experience managing external suppliers and other supply chain issues.Experience with Quality Systems (change control, deviation and investigation).Qualifications & Experience:Minimum 3 years experience. Minimum bachelors degree required.3+ years in QA.Create and revise SOPs.About ASKASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunitiesASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Created: 2025-01-26