_8_4(1)-min_15.png "Vetted Talents logo")
Quality Assurance Specialist
Entry Level8285 bryan dairy road, #200, largo, florida 33777, us, Largo, Florida, United States
Expired On 03 Jul 2025a year ago
About the Job
Description
JOB SUMMARY: Ensures that services adhere to the company’s quality standards. Responsible for developing quality inspection procedures and implementing inspection activities that detect and resolve product or service defects. The QA Specialist must have a general understanding of quality systems including; documentation control, training, deviations, CAPA, complaints, validation, audits, change control, calibrations and supplier management. The QA Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes and controls.
Duties And Responsilities
JOB REQUIREMENTS / QUALIFICATIONS:
JOB SUMMARY: Ensures that services adhere to the company’s quality standards. Responsible for developing quality inspection procedures and implementing inspection activities that detect and resolve product or service defects. The QA Specialist must have a general understanding of quality systems including; documentation control, training, deviations, CAPA, complaints, validation, audits, change control, calibrations and supplier management. The QA Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes and controls.
Duties And Responsilities
- Oversee the generation, review, approval, and archival of controlled documents used to support GxP operations. Ensure consistency and compliance to formatting and template requirements.
- Writing and revising standard operating procedures (SOPs).
- Maintain controlled documentation archive.
- Ensure systems are in compliance with current SOPs and pharmaceutical industry and hazardous waste laws & regulations.
- Participation in QA operational activities, including: change controls, non-conformance/deviation investigations, complaints, CAPA, CAPA effectiveness check, validation of equipment & software, internal and external audits, & approving GxP operations suppliers.
- Participation in Lean process improvement projects.
- Perform internal audits of procedures and processes as assigned.
- Maintain inspection readiness and participate in external and regulatory audits.
- Perform review and approval of deviations and nonconformance as required.
- Assist investigations and resolve potential service & product quality issues to improve efficiency.
- Implement, monitor, and record all corrective and preventive actions taken.
- Perform, review, approve, and record risk management assessments for deviations, validation, supplier management and other processes as required.
- Review and approve validation plans and protocols (IQ/OQ/PQ) for GxP computer systems and equipment.
- Support the establishment and periodic review of the Quality Management System (QMS).
- Manage quality projects as requested by Management and role.
- Maintain schedules and coordinate activities for project efforts.
- Evaluate procedures and coordinate with subject matter experts to identify areas of quality and process improvement.
- Develop and maintain positive relationships with other departments and management.
- May perform additional duties as required.
JOB REQUIREMENTS / QUALIFICATIONS:
- Excellent verbal and written communication skills.
- Excellent organizational and analytical skills and attention to detail.
- Ability to take complex, technical information and translate it for colleagues and consumers who have nontechnical backgrounds.
- Ability to meet deadlines and to work independently.
- Ability to work as part of a team.
- Decision-making skills.
- Proficient with Microsoft Office Suite or related software.
- Prolonged periods sitting at a desk and working on a computer.
- Bachelor’s, or higher, degree in a scientific discipline preferred.
- 2+ years of experience in a GxP environment.
- Lean Six Sigma green belt or higher.
- Preferred: In-depth understanding of industry standards and regulations.
Location :8285 bryan dairy road, #200, largo, florida 33777, us, Largo, Florida, United States, 33777
About the Company
Overview
PharmaLink, Inc. is the nation's premier Pharmaceutical Reverse Distribution provider. With services spanning the complete spectrum of the pharmaceutical supply chain, they have a 360° view of the return processing needs of all businesses involved in the delivery of healthcare. PharmaLink delivers impactful solutions that trim cycle time while safely removing nonsalable products from the marketplace. With a process backed by a powerful enterprise infrastructure, PharmaLink produces accurate processing and analytics that optimize business decisions and increase bottom line. This is all achieved while adhering to stringent regulatory guidelines at the state and federal level. With customizable solutions available for any size client, PharmaLink is the choice provider for pharmaceutical return and disposal solutions.
Skills
Process ImprovementLean ManufacturingQuality ControlSupply Chain ManagementProduction PlanningInventory ManagementSix SigmaEquipment MaintenanceIndustrial EngineeringCost ReductionSafety RegulationsERP Software
Key Details
- Experience:
- Entry Level
- Job Domain/Function:
- Pharmaceutical Manufacturing
- Job Type:
- Onsite
- Employment Type:
- Full-Time
- Number of position(s):
- 1
- Educational qualifications:
- Students & Fresh Graduates