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Essential Responsibilities
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- Supervise the on-site QA Operations staff and oversee their on-the-floor functions, including but not limited to on-site inspection of manufacturing/testing areas and verification of critical process steps.
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- Organize the establishment/maintenance of relevant procedures/documents.
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- Assists all departments in the identification and evaluation of deviations and issues. Assures proper documentation is initiated to capture the event. Organizes communication of issues. Track and trends the issues.
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- Provide appropriate data and QA support for SPL regulatory functions.
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- Coordinates/reviews deviations, investigations, change controls and CAPAs
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- Participates in audits and addresses audit findings where necessary.
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- Responsible for continuous improvement of SPL cGMP Quality Systems to support on-site QA in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
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- Compiles and communicates metrics associated with on-site QA to management as required.
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- Provide a real-time, on-shift QA presence and point of contact for manufacturing and testing operations, making timely, compliant quality decisions to support continuity of operations.
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- Perform raw material release in defined situations (e.g., when QA on-site coverage is unavailable), in accordance with applicable procedures.
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- Perform personnel activities for on-site QA staff, including performance reviews, workload management, shift scheduling and coverage, and coordination of training.
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- Coordinate shift-to-shift handoff of open quality items between shifts.
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Job Requirements and Qualifications:
- Education: Associate’s degree required, Bachelor’s degree or above preferred
- Experience: 5 years’ required, 10 years preferred
- Schedule: 2nd shift, Monday-Friday, 3pm-11pm
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Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
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