Aptask Global Workforce (AGW) is seeking a Quality Specialist - Deviation/CAPA for a Remote position with a Global Biotechnology Company located in Providence, RI. This is a 12+ month contract opportunity. This role supports the Corporate Quality Management System (CQMS) team within the Deviation/CAPA functional area. The specialist will own and approve deviation and CAPA records, provide support for the deviation management system, and contribute to continuous improvement projects related to the Deviation/CAPA process. The position is fully remote, with preference for candidates in EST or PST time zones.
Responsibilities: - Own and/or QA Approve Minor and Major Deviations for the Corporate Quality Management System s (CQMS) team
- Own and/or QA Approve CAPA and Effectiveness Verification (EV) records
- Support annual trend verification report
- Support deviation proficiency evaluation program
- Support system Business Owner responsibilities such as defining user requirements, drafting data integrity assessments, drafting test scripts/protocols for user testing, and ALM testing
- Own and/or QA Approve Deviation & CAPA process documentation including work instructions, SOPs, and training materials
- Coordinate Investigation Advisory Board (IAB) meetings for multisite and CQMS deviations
- Provide support/advice to deviation management system (DQMS) users and approve IS tickets for record updates
- Review and approve Change Controls (QA Contact role)
- Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
- Anticipate and prevent potential problems
- Lead/support continuous improvement projects related to the Deviation/CAPA process
- Provide training for Deviation/CAPA Instructor Led Training sessions
- Independently develop solutions that are thorough, practical and consistent with functional objectives
- Bring critical events or deviations to management s attention and initiate and enforce necessary improvements and corrections
Requirements: - Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- 3+ years of experience after graduating
- Experience with Deviations
- Experience with CAPA
- Overall Quality experience
Desired skills: - Experience owning/approving Major and Minor Deviations
- Technical knowledge of IS systems and validation from Business Owner perspective for systems that are used to support the Deviation process
- Excellent written and verbal communication skills
- Strong organizational skills
- Experience in AI related projects
- Knowledge of industry and business principles
- Demonstrated problem solving abilities
- Demonstrated project management skills
Pay range: up to $29.58 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
