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Quality Compliance Coordinator
$68k-83k (estimate)
Full Time
2 Weeks Ago
Vivex Biologics is Hiring a Quality Compliance Coordinator Near Miami, FL
DescriptionJob purposeThe Quality Compliance Coordinator is primarily responsible for managing and monitoring Corrective Actions & Preventive Actions (CAPA), Non-conformances (NC), Supplier Corrective and Preventive Actions (SCAR), Complaints, Planned Deviations, and Error Corrections. Additionally, the Quality Compliance Coordinator is responsible for managing change controls related to manufacturing product, process, equipment, facility, etc., contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance. This critical Quality role serves as a Change Control Subject Matter Expert in collaboration with internal and external stakeholders to ensure compliance with current site SOP, Corporate Policies, and regulations.
Duties And Responsibilities
Physical RequirementsWhile performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.
Direct reportsNot applicable
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
Duties And Responsibilities
- Administrate Corrective Actions & Preventive Actions (CAPA), Non-conformances (NC), Supplier Corrective and Preventive Actions (SCAR), Complaints, Planned Deviations, and Error Corrections.
- Provide technical guidance and ensure adherence to non-conformance, CAPA, complaints, planned deviation, and error correction procedures.
- Support investigations and root cause analyses for quality-related issues, implementing effective corrective actions.
- Support change control activities by providing expert review and feedback ensuring compliance with applicable procedures and regulations.
- Review and manage Change Controls and associated activities.
- Support the identification of potential risks associated with manufacturing processes and the implementation of appropriate mitigation measures to minimize those risks effectively.
- Review and audit complex documents: batch records, process and method validations.
- Assist with reviewing and providing Quality Management Review and Process Change Control Metrics as assigned.
- Author, review, and approve QMS SOPs and Policies as needed.
- Observe manufacturing activities to support implementation of best practices and improvements.
- Prepare routine updates and project status report of Quality Assurance activities.
- Communicate quality metrics and quality improvement initiatives to leadership.
- Provides oversight and input to Trend Reporting activities to identify and address process shifts and trends.
- Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.
- Supports, prepares, provides Quality training with cross-functional teams as assigned.
- Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
- Reports on project progress to Quality Leadership and cross functional leaders, as appropriate.
- Bachelor’s degree required, preferably in engineering or a related technical/scientific discipline (e.g. Biology, Chemistry, etc.).
- At least 5 years of experience in related Quality or Engineering role.
- Change Control experience is a must.
- Strong knowledge of FDA, AATB, and cGTP guidelines preferred.
- Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
- Experience with Non-Conformance, Planned Deviation, Complaint, and Corrective and Preventive Actions (CAPAs).
- Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint).
- Effective oral, written, communication, and presentation skills.
- Strong organizational and communication skills.
- Strong analytical and problem-solving skills.
- Project management skills preferred.
- Ability to be assertive and influence others and lead significant change.
- American Society for Quality (ASQ) certification preferred.
- Certified Tissue Bank Specialist (CTBS) certification preferred.
Physical RequirementsWhile performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.
Direct reportsNot applicable
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
Job Summary
JOB TYPE
Full Time
SALARY
$68k-83k (estimate)
POST DATE
06/10/2024
EXPIRATION DATE
07/03/2024
WEBSITE
vivex.com
HEADQUARTERS
CUMBERLAND, GA
SIZE
100 - 200
FOUNDED
2013
CEO
LISA COLLERAN
REVENUE
$10M - $50M
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