MaryAnne A. Peters
Harker Heights
Summary
Corporate Investigation Specialist with extensive experience in regulatory compliance and CAPA investigations at Quva Pharma. Skilled in leading cross-functional teams and implementing training programs that drive process improvements and enhance product quality. Expertise in data analysis and communication fosters a culture of safety and compliance across operations.
Overview
13
13
years of professional experience
Work History
Corporate Investigation and Lot Disposition Specialist
Quva Pharma
06.2024 - 06.2025
- Investigated manufacturing incidents and deviations in compliance with established procedures and regulatory guidelines.
- Conducted root cause analysis to identify underlying issues and prevent recurrence.
- Developed corrective and preventive actions (CAPAs) to improve product quality and process reliability.
- Performed impact assessments to evaluate potential effects of deviations on product safety and compliance.
- Maintained detailed documentation of all findings and resolutions.
- Accurately documented all investigation findings, actions, and outcomes in a timely manner.
- Collaborated cross-functionally with Operations and Quality teams to resolve issues and streamline processes.
- Communicated investigation progress and resolution status to leadership.
Sterility Assurance- Aseptic Process Monitor
Quva Pharma
11.2023 - 06.2024
- Ensured compliance with cGMP, SOPs, and Quality Management Systems through routine monitoring of aseptic practices and cleanroom activities.
- Conducted EM/PM plate reading, growth promotion testing, and sterility assurance checks; supported CAPA investigations and root cause analysis.
- Reviewed batch records and documentation for accuracy; assisted in SOP development and updates.
- Trained personnel on aseptic techniques, gowning procedures, and documentation standards.
- Participated in media fills, documentation audits, and cross-functional collaboration to resolve quality issues.
Compounding Lead Technician and Trainer
Quva Pharma
05.2021 - 11.2023
- Supervised daily compounding operations, managed team scheduling and assignments.
- Trained new hires and monitored performance, ensuring compliance with cGMP.
- Initiated and managed work orders for equipment maintenance.
- Fostered a safety-first culture and collaborated across production and quality functions.
In-Patient Pharmacy Technician Supervisor
AdventHealth Central Texas
08.2014 - 07.2020
- Managed hiring, training, performance evaluations, and daily workflow for pharmacy technicians.
- Oversaw automation (Pyxis), controlled substances, and regulatory compliance (DEA).
- Led technical upgrades and supported audits, billing, procurement, and 340B program savings.
- Acted as key liaison with pharmaceutical vendors and internal departments.
In-Patient Pharmacy Technician
AdventHealth Central Texas
06.2012 - 08.2014
- Supported inpatient pharmacy operations including sterile medication preparation, inventory, and distribution.
- Ensured compliance with protocols and supported medication safety reporting.
- Maintained automation systems and collaborated with clinical staff.
Education
MBA - Healthcare Administration
Western Governors University
Salt Lake City, UTBachelor in Secondary Education - Major in General Science
Pangasinan State University
PhilippinesSkills
- Regulatory compliance (FDA, cGMP, SOPs)
- Deviation and CAPA investigations
- Cross-functional team leadership
- Aseptic processing and sterility assurance
- Training and personnel development
- Project and schedule management
- Data analysis and impact assessments
- Document control and technical writing
- Microsoft Office suite (Word, Excel, Access, Outlook)
- ERP and inventory systems (eg, Pyxis, Pharmacy IS)
Timeline
Corporate Investigation and Lot Disposition Specialist
Quva Pharma
06.2024 - 06.2025
Sterility Assurance- Aseptic Process Monitor
Quva Pharma
11.2023 - 06.2024
Compounding Lead Technician and Trainer
Quva Pharma
05.2021 - 11.2023
In-Patient Pharmacy Technician Supervisor
AdventHealth Central Texas
08.2014 - 07.2020
In-Patient Pharmacy Technician
AdventHealth Central Texas
06.2012 - 08.2014
MBA - Healthcare Administration
Western Governors University
Bachelor in Secondary Education - Major in General Science
Pangasinan State University
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