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Compliance Specialist

3 months ago

Springhouse British Columbia, CA Astrix Technology Full time
Astrix Technology Compliance Specialist Springhouse, Pennsylvania Apply Now

Location: Montgomery County, Pennsylvania

Position Type: 1 Year Contract

Pay: 32 - 54/hr (Depending on experience/level)

Job Summary:

We are seeking dynamic Quality Compliance Specialists to join our team, with openings for both entry-level and experienced candidates. This role is crucial in ensuring that bioanalytical data and laboratory systems comply with quality standards, regulatory requirements, and organizational policies. Successful candidates will conduct compliance audits, analyze data, and support continuous improvement initiatives.

Key Responsibilities:

  1. Conduct compliance audits of scientist and engineer records, lab documentation, and departmental processes to ensure accuracy and adherence to established protocols.
  2. Perform laboratory inspections, audits, and investigations, including root cause analyses and corrective actions.
  3. Utilize tools and methods to organize, catalog, and analyze auditing data, generating metrics and tracking analytics to support compliance and improvement.
  4. Develop and implement audit and documentation policies, procedures, and workflows to enhance quality management.
  5. Collaborate with cross-functional teams to ensure compliance with quality management systems, such as Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
  6. Provide clear and concise reports and documentation on audit findings, recommendations, and corrective actions to internal leadership and stakeholders.

Qualifications:

Education: Bachelor’s degree or higher in a science-based, quality, or engineering discipline.

Experience:

Entry-Level (Level 1): Minimum of three years of professional experience in the industry, with foundational experience in quality management systems and laboratory procedures.

Experienced (Level 3): At least 10 years of experience with extensive hands-on experience in quality management systems, standards, and regulatory compliance, including advanced proficiency in performing audits and investigations.

Knowledge and Skills:

  • Strong knowledge of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and related quality standards.
  • Proficiency in performing laboratory inspections, audits, and root cause analyses.
  • Experience with testing procedures, quality metrics, statistical analysis, document control, and risk management processes.
  • Strong attention to detail, analytical and problem-solving skills.
  • Excellent communication and interpersonal skills, with proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) and Laboratory Information Management Systems (LIMS).

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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