Quality Assurance Records Senior Specialist
4 days ago
Quality Assurance Records Senior Specialist Join to apply for the Quality Assurance Records Senior Specialist role at Kelly Science, Engineering, Technology & Telecom. Overview This role is responsible for thoroughly investigating manufacturing-related quality events and delivering well-documented deviation investigation records. The Quality Assurance Records Sr. Specialist will own change control records and manage continuous improvement initiatives that enhance GMP efficiency. Pay Rate $52-64/hr, depending on experience Schedule & Duration Monday-Friday Day Shift, approx. 6 months Responsibilities Own end-to-end deviation investigations and collaborate cross-functionally to ensure a thorough, risk-based investigation is conducted for each quality event commensurate with the event classification. Ensure clarity, accuracy, and compliance of quality event documentation that meets procedural, regulatory, and phase-appropriate expectations. Deliver high-quality deviation investigation reports that are complete, concise, clear, and submitted within defined timelines. Own change control records and manage effective execution and closure by drafting organized, well-structured change action plans and driving implementation. Manage continuous improvement initiatives from concept through execution by tracking progress with owners and stakeholders. Communicate status of investigations, quality event records (Deviations, Change Controls, CAPAs) and continuous improvement projects at cross-functional and manufacturing-specific group meetings. Qualifications Bachelor's degree in Biochemistry, Cell & Molecular Biology, or related life science discipline. Minimum of 8 years of experience with deviation investigation and complex root cause investigational tools (e.g., fishbone, 6M). Ability to gown aseptically and work in a clean room environment, and to work while gowned for extended periods of time. Demonstrated ability to use risk-based decision-making in support of deviation investigation and quality event reporting. Excellent written and verbal communication skills, with experience delivering clear, concise reports in a GMP manufacturing environment. Project management skills, including the ability to independently track, manage, and close multiple quality events simultaneously. What Happens Next Once you apply, youll proceed to next steps if your skills and experience look like a good fit. Even if this position doesnt work out, youre still in the Kelly Science & Clinical network. Equal Employment Opportunity Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. #J-18808-Ljbffr
-
Quality Assurance Records Senior Specialist
2 weeks ago
Louisville, United States Kelly Services Full timeKelly® Science & Clinical is seeking Quality Assurance Records Senior Specialist for a contract position for a company in Louisville, CO. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts. Overview: This role is responsible for thoroughly...
-
Senior Specialist, Quality Assurance
4 days ago
Louisville, United States Kentucky Staffing Full timeQuality Assurance Specialist Quality Assurance contributes to Cardinal Health by developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. This job family provides oversight of production/manufacturing activities, training to operational and quality control...
-
Senior Specialist, Quality Assurance
5 days ago
Louisville, United States Healthcare Distributors Association Full timeWhat Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and...
-
Senior Specialist, Quality Assurance
21 hours ago
Louisville, United States Hobbsnews Full timeWhat Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and...
-
Senior Specialist, Quality Assurance
18 hours ago
Louisville, United States Healthcare Distributors Association Full timeWhat Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and...
-
Senior Specialist, Quality Assurance
2 hours ago
Louisville, KY, United States Healthcare Distributors Association Full timeWhat Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and...
-
Senior Specialist, Quality Assurance
2 hours ago
Louisville, KY, United States Hobbsnews Full timeWhat Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and...
-
Senior Specialist, Quality Assurance
5 days ago
Louisville, United States Umoja Biopharma Full timeUmoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in...
-
Senior Specialist, Quality Assurance
19 hours ago
Louisville, United States Umoja Biopharma Full timeUmoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in...
-
Quality Assurance Specialist
6 days ago
Louisville, Kentucky, United States McKesson Full timeCompany Description McKesson policy now requires all contractors and direct employees to be fully vaccinated prior to beginning employment.McKesson is seeking a dynamic & engaging individual to fill a Quality Assurance Specialist role in our distribution center located in Shepherdsville, KY. This will be a contract role with a potential opportunity to...
