Senior Quality Assurance Specialist

Planet Pharma; Kennesaw (GA); On-site; USD 80,000 - 90,000; Full time

Job summary

Une entreprise de premier plan dans la fabrication d'équipements médicaux recherche un Spécialiste en Assurance Qualité pour renforcer ses processus de gestion de la qualité. Le candidat idéal aura une expérience solide dans l'industrie pharmaceutique ou des dispositifs médicaux, et devra contribuer à l'élaboration et à l'implémentation des systèmes de qualité. Ce poste est une excellente opportunité pour ceux qui souhaitent progresser dans un environnement dynamique et en constante évolution.

Qualifications

• Expérience de 5-10 ans en assurance qualité dans l'industrie pharmaceutique ou des dispositifs médicaux.
• Fluente en anglais; le français est un plus.
• Expérience en audit interne souhaitée.

Responsibilities

• Contribuer à définir les standards et objectifs de qualité de l'organisation.
• Gérer et maintenir la documentation du QMS.
• Identifier, enquêter, et gérer des incidents de qualité.

Skills

Quality Management Systems (QMS)

Quality Assurance (QA)

Good Clinical Practices (GCP)

Communication

Organizational Skills

Teamwork

Education

Bachelor’s degree in Quality, Safety, and Environment (QSE) or Biomedical Engineering

Tools

QMS Tools

Job description

80k - 90k - may have some flexibility for the right person

MUST HAVE:

• 5-10+ years of QA experience
• Global QA experience
• Pharma, biotech or medical device industry experience
• GCP regulation experience preferred

Key Roles and Responsibilities:

Design and Maintenance of the QMS:

Contribute to defining the Group’s quality standards and objectives.

Coordinate the drafting and validating QMS policies and procedures in collaboration with management.

Manage and maintain QMS documentation.

Ensure the QMS aligns with organizational needs and customer requirements.

Develop and implement QMS monitoring tools.

Implementation of Policies and Procedures:

Communicate QMS policies and procedures effectively to stakeholders.

Organize and facilitate necessary training programs to ensure understanding and compliance.

Oversee the Training Process and identify opportunities for improvement.

Continuously enhance the QMS to align with evolving business needs and best practices.

Process Compliance and Incident Management:

Identify, investigate, report, and manage quality incidents.

Collaborate with managers to define and implement corrective and preventive actions (CAPAs).

Monitor QMS deviations and ensure timely resolution.

Document compliance activities and report on action plans to the VP of Global Operations.

Licensing and Certification Management:

Coordinate the application and renewal of operational pharmaceutical licenses and certifications.

Manage related documentation to maintain compliance.

Audit Participation:

Participate in internal audits to identify gaps and monitor corrective actions.

Organize and coordinate customer audits, including preparation, key personnel involvement, and follow-up on findings and action plans.

Support selecting and evaluating suppliers impacting the QMS and Good Clinical Practices (GCP).

Conduct supplier audits and performance evaluations based on risk analysis.

Client Qualification Process:

Coordinate responses to client RFIs (Requests for Information).

Promotion of Quality Culture:

Advocate for a quality-driven mindset within the organization.

Actively market QA initiatives and foster team engagement in quality practices.

Profile Requirements:

Bachelor’s degree in Quality, Safety, and Environment (QSE), Biomedical Engineering, or a related field.

Proven experience in the medical sector with QMS, QA, and internal auditing responsibilities.

Fluency in English (French or additional foreign languages is a plus).

Proficiency in computing systems and QMS tools.

Strong communication, organizational, and teamwork skills with an autonomous and results-oriented approach.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Planet Pharma by 2x

Get notified about new Quality Assurance Specialist jobs in Kennesaw, GA.

Atlanta, GA $58,700.00-$79,400.00 3 days ago

Quality Assurance Specialist / Regulatory Affairs

Atlanta, GA $110,000.00-$145,000.00 6 days ago

Dunwoody, GA $60,000.00-$70,000.00 3 weeks ago

Atlanta, GA $100,000.00-$140,000.00 2 weeks ago

Atlanta, GA $105,000.00-$125,000.00 2 weeks ago

(USA) Area Manager - Quality Assurance/Systems

Atlanta, GA $65,500.00-$98,000.00 4 days ago

Quality Assurance Analyst (Contract Opportunity)

(USA) Quality Assurance/Systems Manager (Import, Regional, Returns, Wm.Com)

Atlanta, GA $84,000.00-$126,000.00 4 days ago

QA/QC Specialist - Environmental Lab Chemistry & Fuels (In Ofc Full Time)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.