Senior Quality Management Systems Specialist
Amneal Pharmaceuticals
13 hours ago
Remote friendly (Brookhaven, NY)
United States
Operations
Essential Functions:
- Review and approve (as applicable) data for change, implementation, analysis, and reporting; collect/generate data; support preliminary investigations and prepare summary findings to support NOIs, CAPAs, complaints, and other quality activities; audit tasks to identify outstanding actions for Sterile and Non-Sterile Quality Operations.
- Review change controls and planned deviations; provide approvals (as applicable); issue tasks; monitor due dates and ensure follow-up until tasks/events are closed; coordinate preparation/review/approval of NPLs (New Product Launches) within required timeframes; maintain and track agency commitments for Sterile and Non-Sterile Quality Operations.
- Prepare, review, and present/submit quality data using statistical approaches; serve as subject matter expert for electronic QMS.
- Provide senior quality management leadership with timely data analysis/insights; propose corrective actions and applicable improvements.
- Notify QM management of activities/decisions that could impact site compliance and potential regulatory action; ensure extension documentation when due dates can’t be met due to ongoing activities.
- Collaborate with other functional areas to resolve quality issues/concerns; distribute associated documentation as applicable.
- Act as point of contact for external audits; maintain required concurrent documentation supporting regulatory audits.
- Audit investigations and CAPA schedules to report status and identify outstanding actions.
Additional Responsibilities:
- Assist with internal and regulatory audits; analyze, display, and customize data reports (e.g., scorecards and presentations) on bi-weekly/monthly/quarterly cadence.
Qualifications:
- Education: Bachelor’s degree (BA/BS) with related QA experience for Sterile & Non-Sterile Ops (Required).
- Experience: 4+ years in related QA field experience.
- Specialized Knowledge/Skills: Organized and able to communicate clearly; present data/trends in an easily understood, relatable way.
- Additional Requirement: Successful completion of an OSHA-compliant Respirator Fit Test.
Benefits/Compensation (if applicable in posting): Base salary $105,000–$115,000 per year; comprehensive benefits and 401(k) matching contribution.
- Review and approve (as applicable) data for change, implementation, analysis, and reporting; collect/generate data; support preliminary investigations and prepare summary findings to support NOIs, CAPAs, complaints, and other quality activities; audit tasks to identify outstanding actions for Sterile and Non-Sterile Quality Operations.
- Review change controls and planned deviations; provide approvals (as applicable); issue tasks; monitor due dates and ensure follow-up until tasks/events are closed; coordinate preparation/review/approval of NPLs (New Product Launches) within required timeframes; maintain and track agency commitments for Sterile and Non-Sterile Quality Operations.
- Prepare, review, and present/submit quality data using statistical approaches; serve as subject matter expert for electronic QMS.
- Provide senior quality management leadership with timely data analysis/insights; propose corrective actions and applicable improvements.
- Notify QM management of activities/decisions that could impact site compliance and potential regulatory action; ensure extension documentation when due dates can’t be met due to ongoing activities.
- Collaborate with other functional areas to resolve quality issues/concerns; distribute associated documentation as applicable.
- Act as point of contact for external audits; maintain required concurrent documentation supporting regulatory audits.
- Audit investigations and CAPA schedules to report status and identify outstanding actions.
Additional Responsibilities:
- Assist with internal and regulatory audits; analyze, display, and customize data reports (e.g., scorecards and presentations) on bi-weekly/monthly/quarterly cadence.
Qualifications:
- Education: Bachelor’s degree (BA/BS) with related QA experience for Sterile & Non-Sterile Ops (Required).
- Experience: 4+ years in related QA field experience.
- Specialized Knowledge/Skills: Organized and able to communicate clearly; present data/trends in an easily understood, relatable way.
- Additional Requirement: Successful completion of an OSHA-compliant Respirator Fit Test.
Benefits/Compensation (if applicable in posting): Base salary $105,000–$115,000 per year; comprehensive benefits and 401(k) matching contribution.