Kelly Science, Engineering, Technology & Telecom
Senior Quality Assurance Specialist
Kelly Science, Engineering, Technology & Telecom, Louisville, Colorado, United States, 80028
Kelly® Science & Clinical is seeking
Senior Quality Assurance Specialist
for a 6-month
contract
position at a leading biotech company in
Louisville, CO.
Pay Range:
$52.00/hr – $64.00/hr (based on experience and skills).
Overview This role is responsible for thoroughly investigating manufacturing-related quality events and delivering well-documented deviation investigation records. The Senior Quality Assurance Specialist will also own change control records and will be expected to manage continuous improvement initiatives that enhance GMP efficiency.
Responsibilities
Own end-to-end deviation investigations and effectively 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 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; ability to work while gowned for extended periods of time, including standing 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 proven ability to deliver clear, concise reports in a GMP manufacturing environment.
Project management skills, including the ability to independently track, manage, and close multiple quality events simultaneously.
Seniority Level:
Mid‑Senior level
Employment Type:
Contract
Job Function:
Quality Assurance
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Senior Quality Assurance Specialist
for a 6-month
contract
position at a leading biotech company in
Louisville, CO.
Pay Range:
$52.00/hr – $64.00/hr (based on experience and skills).
Overview This role is responsible for thoroughly investigating manufacturing-related quality events and delivering well-documented deviation investigation records. The Senior Quality Assurance Specialist will also own change control records and will be expected to manage continuous improvement initiatives that enhance GMP efficiency.
Responsibilities
Own end-to-end deviation investigations and effectively 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 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; ability to work while gowned for extended periods of time, including standing 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 proven ability to deliver clear, concise reports in a GMP manufacturing environment.
Project management skills, including the ability to independently track, manage, and close multiple quality events simultaneously.
Seniority Level:
Mid‑Senior level
Employment Type:
Contract
Job Function:
Quality Assurance
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