Kelly Science, Engineering, Technology & Telecom
Quality Assurance Records Senior Specialist
Kelly Science, Engineering, Technology & Telecom, Louisville, Colorado, United States, 80028
Quality Assurance Records Senior Specialist
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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, you’ll proceed to next steps if your skills and experience look like a good fit. Even if this position doesn’t work out, you’re 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.
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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, you’ll proceed to next steps if your skills and experience look like a good fit. Even if this position doesn’t work out, you’re 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