JoAnna Nieves
Philadelphia,PA
Summary
Quality Assurance Manager with a robust background in quality management systems and regulatory compliance. Proven success in leading audit readiness and enhancing team capabilities, driving operational excellence while ensuring adherence to industry standards.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager
ImmunoTek Bio Centers, LLC
Wilmington, DE
12.2025 - Current
- Oversee the implementation and maintenance of the center's Quality Management System to ensure compliance with all applicable SOPs, regulatory requirements, and internal quality expectations.
- Lead internal and external audit readiness, including documentation, self-assessments, CAPA response, implementation, and effectiveness checks.
- Manage the deviation management system, ensuring timely investigation, root cause analysis, CAPA development, and follow-up.
- Supervised Quality Technicians by scheduling work assignments, coaching, providing performance feedback, and managing disciplinary actions.
- Ensured compliance with training requirements, SOPs, processes, and regulatory directives, supporting operational quality standards and reducing compliance risks.
- Oversaw administration and submission of the center's Proficiency Testing process, evaluating equipment and supply readiness to maintain testing integrity.
- Support center readiness for regulatory inspections by maintaining real-time documentation and facilitating pre-inspection preparation activities.
Quality Assurance Manager
ImmunoTek Bio Centers, LLC
Wilson, NC
03.2025 - 12.2025
- Oversee the implementation and maintenance of the center's Quality Management System to ensure compliance with all applicable SOPs, regulatory requirements, and internal quality expectations.
- Lead internal and external audit readiness, including documentation, self-assessments, CAPA response, implementation, and effectiveness checks.
- Managed deviation management system, facilitating timely investigations, root cause analyses, CAPA development, and follow-ups to ensure quality compliance.
- Ensure compliance with training requirements, SOPs, processes, and all regulatory or company directives to support operational and quality standards.
- Supervised Quality Technicians, coordinating scheduling, work assignments, coaching, performance feedback, and disciplinary actions to enhance team effectiveness.
- Oversaw administration and performance of center's Proficiency Testing process, evaluating equipment and supply readiness to maintain testing integrity.
- Support center readiness for regulatory inspections by maintaining real-time documentation and facilitating pre-inspection preparation activities.
Assistant Manager of Operations
ImmunoTek Bio Centers, LLC
Wilson, NC
07.2023 - 03.2025
- Oversaw donor center operations in absence of Center Manager, ensuring continuity of services.
- Ensures compliance with all federal, state, local, and company-specific rules, regulations, and practices related to the quality and safety of products, donors, and employees.
- Worked with center leadership to develop action plans to maximize center efficiency.
- Handled all personnel functions, including hiring, work assignments, training development, disciplinary actions, and maintenance of personnel records.
- Partnered with training department to facilitate staff training and achieve training goals.
- Responsible for being proficient in all areas of the donor collection process.
Quality Assurance Manager
KEDPlasma LLC
Columbia, SC
03.2023 - 06.2023
- Oversaw product quality activities, ensuring compliance with regulations and company standards to uphold product integrity.
- Coordinated, monitored, and facilitated all QA activities to meet FDA, EMEA, and customer requirements.
- Collaborated with Center Manager to sustain high product quality and meet regulatory compliance objectives.
- Ensured production personnel followed cGMP, DCOPs, and company protocols.
- Reviewed and investigated final shipment release deviations, ensuring accurate labeling and documentation.
- Reviewed and approved all DCOPs prior to implementation, confirming alignment with statutory and regulatory requirements.
- Determined existence and accuracy of DCOPs for all manufacturing procedures.
- Investigated, tracked, and followed up on corrective actions and preventative measures for nonconformances.
Quality Assurance Manager
ImmunoTek Bio Centers, LLC
Columbia, SC
07.2022 - 03.2023
- Managed quality personnel functions, including hiring, training, performance management to ensure team effectiveness.
- Supervised Quality Assurance Unit employees and partnered with management to ensure compliance.
- Oversaw product collection, sample submission, testing results to ensure compliance with quality standards.
- Tracked and trended quality, operational metrics to identify areas for continuous improvement.
- Interpreted and applied SOPs, ensuring revisions were implemented efficiently.
- Managed document control and suggested necessary SOP changes.
- Facilitated and evaluated center and equipment readiness for operations.
- Ensured donor center records and shipments were complete, accurate, and properly labeled.
Supervisor of Quality and Training
ImmunoTek Bio Centers, LLC
Columbia, SC
04.2021 - 07.2022
- Coordinated training activities for new hires and regulatory requirements to enhance employee preparedness.
- Reviewed and updated training documents to ensure compliance with procedures and regulations.
- Collaborated with management to develop and implement continuous improvement plans.
- Conducted compliance audits and developed corrective action plans to address identified deficiencies.
- Performed employee observations and initiated corrective actions.
- Investigated and closed deviation reports, ensuring effective corrective actions.
- Maintained the center's Safety Program and promoted safety practices.
- Supported the center quality program, including donor records and equipment review.
Quality Technician
ImmunoTek Bio Centers, LLC
Columbia, SC
07.2021 - 04.2022
- Reviewed donor records and conducted equipment quality control checks to ensure compliance with standards.
- Inspected and released incoming supplies, documenting deviation reports to address quality issues.
- Investigated and reported non-compliant supplies to uphold quality specifications.
- Conducted root cause analysis for deviations and customer complaints.
- Reviewed medical reports, equipment incidents, and sample shipments for compliance.
- Assisted Manager of Quality Assurance with compliance to regulations and internal procedures.
- Reviewed and approved deferred donor reinstatement activities and lookback information.
Donor Center Technician
ImmunoTek Bio Centers, LLC
Sumter, SC
11.2020 - 07.2021
- Set up and disconnected donors for plasmapheresis procedures, prioritizing safety and maintaining accurate documentation.
- Performed pre-donation medical screening and health assessments for donors.
- Managed donor flow and verified registration for new donors to streamline the donation process.
- Monitored equipment for alerts and took appropriate action per SOPs.
- Conducted quality calibrations and cleaning activities to uphold standards and ensure equipment reliability.
- Maintained open communication with management and provided excellent customer service.
- Ensured regular attendance and adherence to company policies.
Assistant Manager
Young's Gas Station
Sumter, SC
02.2019 - 05.2021
- Assisted Store Manager in meeting profit and sales targets through operational support.
- Coordinated work schedules and managed daily operations to optimize staff efficiency.
- Maintained high store standards in housekeeping, merchandising, and service.
- Addressed customer needs and resolved issues to build long-term relationships.
- Executed regular deposits and maintained accurate reporting to uphold company policies.
- Performed spot inventory counts and checks to ensure data accuracy.
Assistant Store Manager
Family Dollar
Sumter, SC
08.2016 - 02.2019
- Supervised, trained, and developed store team members.
- Supported Store Manager in loss prevention initiatives and management tasks.
- Greeted and assisted customers, resolving inquiries and enhancing customer satisfaction.
- Maintained clean, well-stocked store, ensuring positive shopping experience.
- Assisted with merchandise unloading, organization, and record keeping.
Life Skills Specialist
Epworth Children's Home
Columbia, SC
07.2013 - 02.2016
- Taught life skills and relationship skills to children and adolescents.
- Guided children in navigating everyday crises, promoting resilience and confidence in problem-solving skills.
- Exhibited positive behaviors and attitudes to motivate and empower youth in a mentoring program, enhancing their self-esteem and interpersonal skills.
- Delivered daily care and support to children and youth in foster care, fostering a stable environment for emotional and social development.
- Assisted with school preparation and homework.
Direct Support Professional
The Mentor Network
Columbia, SC
01.2013 - 04.2014
- Assisted individuals in community-based settings with daily activities and personal care to enhance independence and quality of life.
- Supported meal preparation and medication administration while planning activities to encourage health and well-being.
- Facilitated community involvement by accompanying individuals on outings, promoting social engagement and connection.
Education
High school diploma or GED -
Pinecrest Annex
Aiken, SCSome College (No Degree) - Criminal Justice
ITT Technical Institute
RemoteSkills
- Quality Assurance
- Quality management
- Quality audits
- Internal Audits
- CGMP
- GMP
- FOSHA regulations
- Continuous improvement
- Root Cause Analysis
- Data Analysis Tools
- Data collection
- Manufacturing
- GMP
- Team Management
- Staff development
Certification
- Driver's License, Present
- Forklift Certification, 08/01/16, 08/01/18
Personal Information
- Willing To Relocate: Yes
- Authorized To Work: US for any employer
Timeline
Quality Assurance Manager
ImmunoTek Bio Centers, LLC
12.2025 - Current
Quality Assurance Manager
ImmunoTek Bio Centers, LLC
03.2025 - 12.2025
Assistant Manager of Operations
ImmunoTek Bio Centers, LLC
07.2023 - 03.2025
Quality Assurance Manager
KEDPlasma LLC
03.2023 - 06.2023
Quality Assurance Manager
ImmunoTek Bio Centers, LLC
07.2022 - 03.2023
Quality Technician
ImmunoTek Bio Centers, LLC
07.2021 - 04.2022
Supervisor of Quality and Training
ImmunoTek Bio Centers, LLC
04.2021 - 07.2022
Donor Center Technician
ImmunoTek Bio Centers, LLC
11.2020 - 07.2021
Assistant Manager
Young's Gas Station
02.2019 - 05.2021
Assistant Store Manager
Family Dollar
08.2016 - 02.2019
Life Skills Specialist
Epworth Children's Home
07.2013 - 02.2016
Direct Support Professional
The Mentor Network
01.2013 - 04.2014
High school diploma or GED -
Pinecrest Annex
Some College (No Degree) - Criminal Justice
ITT Technical Institute