Quality Assurance Compliance Analyst

2 weeks ago

Upper Gwynedd Twp, United States Spectraforce Technologies Full time

Compliance Specialist

Company: Spectraforce Technologies

Position Overview:

The Compliance Specialist will be instrumental in upholding adherence to regulatory standards, quality benchmarks, and operational protocols within the organization. This role is pivotal in ensuring that all laboratory and data management practices meet the required compliance criteria.

Qualifications:

Education:
  • Bachelor's Degree or higher in a scientific, quality, or engineering field.
  • Formal training in quality assurance, including statistical process control, is advantageous.

Experience:
  • A minimum of three years of relevant professional experience.
  • Extensive knowledge and practical experience with quality management systems and industry regulations, such as Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
  • Proficient in conducting laboratory inspections, audits, and investigations.
  • Experience with quality metrics and statistical analysis.
  • Familiarity with document control and risk management processes.
  • Collaborative experience with cross-functional teams to promote compliance and continuous improvement.

Skills and Competencies:
  • Meticulous attention to detail in reviewing documentation for compliance with established standards.
  • Strong analytical and problem-solving abilities to address quality-related issues.
  • Excellent communication skills for effective collaboration and reporting.
  • Proficient in quality data documentation and tracking tools.
  • Exceptional written and verbal communication skills.
  • Advanced computer skills, including proficiency in Excel, Word, PowerPoint, and LIMS.
  • Logical and sound approach to problem-solving.
  • Strong collaboration skills with teams and stakeholders.

Key Responsibilities:

The Compliance Specialist will oversee the quality compliance audits related to bioanalytical data and laboratory systems. This role includes maintaining comprehensive auditing records, preparing analytical reports, and monitoring compliance outcomes to ensure data integrity and continuous enhancement.


Audit Responsibilities:
  • Conduct thorough audits of laboratory records to verify completeness and accuracy.
  • Review departmental processes related to bioanalytical data and lab systems.
  • Prepare documentation for audits conducted by internal staff.
  • Identify and recommend improvements for record-keeping and process efficiency.
  • Engage in regulatory and accreditation survey preparations and follow-ups.
  • Audit records pertaining to general departmental functions.
  • Maintain detailed records of audit findings and recommendations.
  • Educate staff on audit outcomes and necessary corrections.
  • Report findings to leadership and ensure follow-up on corrective actions.
  • Develop and refine audit policies and procedures.

Analytics and Support:
  • Utilize analytical tools to organize and assess auditing data.
  • Perform statistical analysis on audit data to generate relevant metrics.
  • Engage in performance improvement initiatives and collaborate with quality assurance teams.
  • Participate in departmental committees and ongoing professional development.

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