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Quality Assurance Specialist
2 months ago
We are seeking a highly detail-oriented and organized Quality Assurance Specialist to join our team at MeriCal, LLC. As a key member of our quality assurance team, you will be responsible for ensuring our products meet the highest standards of quality and regulatory compliance.
Key Responsibilities- Manage and maintain training records, SOPs, and other controlled documents to ensure compliance with regulatory requirements and company policies.
- Oversee the development and implementation of quality management systems, including cGMP onboarding, training, and audits.
- Lead product complaint investigations, respond to customers, and ensure closure within 30 days.
- Review and document calibration results, and support maintenance with updating the master calibration list.
- Perform QMS internal audits, manage activities related to annual customer certification and third-party audits, and ensure readiness for regulatory inspections.
- Assist with FDA recalls/withdrawals by researching, submitting, conducting monthly effectiveness checks, and updating the FDA, CAPA, and customers.
- Generate KPIs for complaints, CAPAs, changes, internal/external audits, training, and other areas as required.
- Ensure compliance with FDA's Foreign Supplier Verification Program (FSVP) under FSMA by collecting food safety system documentation from the procurement team.
- Prioritize tasks in a high-pressure, deadline-driven environment.
- Complete pre-audit questionnaires, GMP certificates, licenses, and registrations for contract customers.
- 3+ years of experience related to quality in an industry regulated by 21 CFR Parts 111, 117, 210/211. Part 111 is highly preferred.
- Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously.
- Excellent verbal and written communication, understanding instructions in English.
- Strong written and verbal communication skills.
- Ability to work independently with limited supervision.
- Proficient with Microsoft Office Suite and related software.
- ERP Systems (SAGE).
- Minimum High school diploma. Bachelor's degree preferred.
- Training in FDA Regulatory compliance 21 CFR Part 111, 210/211.
- Certified Quality GMPs.
- Certificates of Completion from ASQ, Train the Trainer Course, PCQI, etc.
- No cost vision insurance, employer-paid life insurance, 12 paid company holidays, generous paid time off benefits and sick time, employee assistance program, and a comprehensive wellness program.
- Affordable medical and dental insurance plans that fit the needs for you and your dependents.
- Outstanding supplemental benefits, including Accident, Critical Illness, Hospitalization indemnity plans, and pet insurance.
- Matching 401k plan and more.
