ClinLab Staffing
The QA Operations Specialist will play a hands‑on role supporting day‑to‑day GMP manufacturing activities by ensuring all quality processes and documentation meet compliance standards. This individual will help manage core elements of the Quality Management System (QMS), including deviations, CAPAs, investigations, change controls, and batch record review. The position works closely with Manufacturing, Facilities, Supply Chain, and Process Development to promote a strong quality culture and ensure consistent adherence to regulatory expectations in a dynamic biologics production environment.
Key Responsibilities
Provide QA oversight and support for manufacturing operations in real time.
Review and approve GMP documentation, including batch records, deviations, change controls, and CAPAs.
Review and approve commissioning, qualification, calibration, and maintenance documentation for equipment and facilities.
Support investigations and review of environmental monitoring excursions and related quality events.
Participate in project team meetings and represent QA in cross‑functional discussions.
Contribute to continuous improvement initiatives and updates to QMS procedures.
Ensure all quality processes and records comply with current GMP standards and internal policies.
Qualifications
BS/MS Degree in a scientific or technical field.
Strong Quality Assurance experience within a biologics, pharmaceutical, or related GMP‑regulated industry.
Strong understanding of GMP regulations and international quality guidelines.
Skilled in writing and managing investigations, risk assessments, and deviation reports.
Excellent written and verbal communication skills with the ability to work effectively across departments.
Highly organized with strong attention to detail and ability to handle multiple priorities.
Proficiency in MS Office and familiarity with GMP‑related electronic systems (e.g., LIMS, QMS, document control platforms).
Able to work independently and maintain accuracy in a fast‑paced environment.
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Key Responsibilities
Provide QA oversight and support for manufacturing operations in real time.
Review and approve GMP documentation, including batch records, deviations, change controls, and CAPAs.
Review and approve commissioning, qualification, calibration, and maintenance documentation for equipment and facilities.
Support investigations and review of environmental monitoring excursions and related quality events.
Participate in project team meetings and represent QA in cross‑functional discussions.
Contribute to continuous improvement initiatives and updates to QMS procedures.
Ensure all quality processes and records comply with current GMP standards and internal policies.
Qualifications
BS/MS Degree in a scientific or technical field.
Strong Quality Assurance experience within a biologics, pharmaceutical, or related GMP‑regulated industry.
Strong understanding of GMP regulations and international quality guidelines.
Skilled in writing and managing investigations, risk assessments, and deviation reports.
Excellent written and verbal communication skills with the ability to work effectively across departments.
Highly organized with strong attention to detail and ability to handle multiple priorities.
Proficiency in MS Office and familiarity with GMP‑related electronic systems (e.g., LIMS, QMS, document control platforms).
Able to work independently and maintain accuracy in a fast‑paced environment.
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