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On-Site
Compensation:
$65 - $75 / hr
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This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is fully on-site.
Job DescriptionThe Quality Assurance Specialist provides oversight of facility and equipment maintenance, calibration, and control programs to ensure compliance with regulatory standards and internal procedures. This role supports investigations, reviews quality records, and partners with cross-functional teams to maintain a compliant and efficient facility environment.
Key Responsibilities
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Provide QA oversight of facility and equipment preventive maintenance, calibration, and related control programs.
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Review and approve work orders, change controls, deviations, and CAPAs.
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Support investigations, including root cause analysis and corrective action implementation.
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Monitor quality metrics, identify trends, and recommend improvements.
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Provide guidance during facility shutdowns and return-to-service readiness activities.
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Collaborate with operations, engineering, and quality teams to ensure compliance and timely issue resolution.
Knowledge and Skills
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Strong collaboration, teamwork, and communication skills.
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Ability to manage multiple priorities in a fast-paced environment.
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Proficiency with project management tools and quality systems.
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Critical thinking, problem-solving, and risk-based decision-making.
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Attention to detail and ability to work independently.
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Prior life sciences or regulated industry background strongly preferred; large company or complex environment experience is a plus.
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An engineering degree is not required but may be beneficial.
Education and Experience
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Bachelor’s degree in a scientific, engineering, or related field with 8+ years of relevant experience, or Master’s degree with 3–5 years of experience.
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Experience with investigations, CAPAs, and change controls.
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Familiarity with facility, equipment, or utility qualification activities in a GMP or similar regulated environment.
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