Specialist Quality Assurance

$25 - $27 per hour

Aditi Consulting

Providence, RI

Job Description

Payrate: $25.00 - $27.00/hr

Responsibilities:

Own and/or QA Approve Minor and Major Deviations for the Corporate Quality Management System’s (CQMS) team – Deviation/CAPA functional area and Corporate functions that do not have Quality oversight
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, 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 (e.g., Qualitative information, Quantitative research, Trend data)
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 to established systems and processes
Admin activities may include the following: maintenance of Deviation/CAPA Smartsheets and distribution lists, querying in deviation management system for data collection/analysis, data gathering for metrics

Preferred Qualifications & 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
Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
Provides training and guidance to others
Extends capabilities by working closely with senior staff/ experts within the internal organization

Top 3 Must Have Skill Sets:

Deviation experience
CAPA experience
Overall Quality experience
3 YOE after graduating

Pay Transparency: The typical base pay for this role across the U.S. is: $25.00 - $27.00/hr . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.

Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to :messages or by contacting View email address on ziprecruiter.com .

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Vacancy posted 2 days ago

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