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Quality Assurance Compliance Analyst

2 months ago

Upper Gwynedd Twp, United States Spectraforce Technologies Full time

Compliance Specialist

Company: Spectraforce Technologies

Position Overview:

The Compliance Specialist will be integral in upholding adherence to established policies, quality benchmarks, operational protocols, and regulatory standards. This role encompasses the execution of quality compliance evaluations of scientific and engineering documentation, alongside laboratory systems, while ensuring meticulous record-keeping and reporting.

Key Qualifications:

  • A Bachelor's Degree or higher in a science-related, quality, or engineering field.
  • Formal training in quality management, including statistical process control, is advantageous.

Experience Requirements:

  • At least three years of relevant professional experience in the industry.
  • Comprehensive knowledge and practical experience with quality management systems, standards, and regulations pertinent to the sector, such as Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
  • Expertise in conducting laboratory inspections, audits, investigations, root cause analyses, and implementing corrective actions.
  • Familiarity with testing protocols, quality metrics, and statistical evaluations.
  • Experience in document control, change management, and risk assessment processes.
  • Proven ability to collaborate with cross-functional teams to promote compliance and continuous enhancement.

Essential Skills:

  • Exceptional attention to detail in reviewing technical documentation to ensure compliance with established standards.
  • Strong analytical and problem-solving capabilities to address quality-related challenges.
  • Effective communication and interpersonal skills for collaboration with teams and stakeholders.
  • Proficiency in utilizing tools for documenting and tracking quality data.
  • Excellent written and verbal communication skills, with the ability to influence positively.
  • High proficiency in computer applications including Excel, Word, PowerPoint, Outlook, and LIMS.
  • A logical and systematic approach to problem-solving.
  • Strong collaborative skills with team members and stakeholders.

Primary Responsibilities:

The Compliance Specialist will conduct quality compliance audits of scientific and engineering records and laboratory systems, maintaining comprehensive auditing documentation, preparing analytical reports, and monitoring compliance outcomes to ensure data integrity and continuous improvement.


Audit Responsibilities:

  • Execute audits of scientific and engineering records to verify completeness and accuracy.
  • Review departmental records and processes associated with bioanalytical data and laboratory systems.
  • Prepare documentation for audits conducted by other personnel.
  • Identify areas for enhancing the quality and efficiency of records and processes.
  • Engage in the preparation and follow-up for regulatory and accreditation assessments.
  • Maintain thorough auditing data, including findings and recommendations.
  • Communicate audit findings and recommendations to internal leadership.
  • Develop policies and procedures for auditing and documentation management.

Analytics and Reporting:

  • Utilize various tools and systems to organize and analyze auditing data.
  • Conduct statistical analysis on auditing data to produce metrics and tracking analytics.

Departmental Collaboration:

  • Participate in performance improvement initiatives.
  • Collaborate with other quality assurance roles within the organization.
  • Engage in departmental committees and workgroups.
  • Provide backup support for quality and regulatory functions.
  • Commit to ongoing training and professional development.