Senior Quality Management Systems Specialist
Amneal Pharmaceuticals
June 24, 2026
Remote friendly (Brookhaven, NY)
United States
Operations
The Sr. Quality Management Systems Specialist provides coordination and reporting, including data collection/generation, data analysis, and data review/interpretation. Prepares summary findings to support change controls, planned deviations, new product launch compliance, and quality assurance trends.
Essential Functions:
- Review/approve data (where applicable); collect/generate data; support preliminary investigations; prepare findings to support NOIs, CAPAs, complaints, and other quality activities/projects; audit reporting for outstanding actions (Sterile and Non-Sterile).
- Review change controls and planned deviations; provide approvals (where applicable); issue/track tasks and due dates; follow up until closure; coordinate NPL (New Product Launch) preparation/review/approval; maintain/track agency commitments for Sterile and Non-Sterile submissions.
- Prepare/review/present/submit quality data using statistical approaches; serve as subject matter expert for electronic QMS.
- Provide leadership with timely data insights; propose corrective actions and improvements; notify QM management of activities impacting site compliance; ensure extension documentation for missed due dates.
- Collaborate cross-functionally to resolve quality issues and distribute documentation as needed.
- Point of contact for external audits; maintain concurrent documentation for regulatory audits; audit Investigations and CAPA schedules.
Additional Responsibilities:
- Assist with internal/regulatory audits; create and customize scorecards/presentations (bi-weekly/monthly/quarterly).
Qualifications:
- B.S./B.A. in Pharmacy, Chemistry, Biotechnology, or related field (Required).
- 4+ years related QA experience.
- Organized, creative, clear communication; ability to present data/trends clearly.
- Successful completion of an OSHA-compliant Respirator Fit Test (Required).
Compensation/Benefits:
- Base salary: $105,000–$115,000/year; competitive benefits and 401(k) matching.
Essential Functions:
- Review/approve data (where applicable); collect/generate data; support preliminary investigations; prepare findings to support NOIs, CAPAs, complaints, and other quality activities/projects; audit reporting for outstanding actions (Sterile and Non-Sterile).
- Review change controls and planned deviations; provide approvals (where applicable); issue/track tasks and due dates; follow up until closure; coordinate NPL (New Product Launch) preparation/review/approval; maintain/track agency commitments for Sterile and Non-Sterile submissions.
- Prepare/review/present/submit quality data using statistical approaches; serve as subject matter expert for electronic QMS.
- Provide leadership with timely data insights; propose corrective actions and improvements; notify QM management of activities impacting site compliance; ensure extension documentation for missed due dates.
- Collaborate cross-functionally to resolve quality issues and distribute documentation as needed.
- Point of contact for external audits; maintain concurrent documentation for regulatory audits; audit Investigations and CAPA schedules.
Additional Responsibilities:
- Assist with internal/regulatory audits; create and customize scorecards/presentations (bi-weekly/monthly/quarterly).
Qualifications:
- B.S./B.A. in Pharmacy, Chemistry, Biotechnology, or related field (Required).
- 4+ years related QA experience.
- Organized, creative, clear communication; ability to present data/trends clearly.
- Successful completion of an OSHA-compliant Respirator Fit Test (Required).
Compensation/Benefits:
- Base salary: $105,000–$115,000/year; competitive benefits and 401(k) matching.