Compliance Specialist

Job Title: Compliance Specialist
Job Location: Lower Gwynedd Township, PA
Job Duration: 12 months+
 
Pay Range: $32.77/hr. on w2
 
Description:
The Quality Compliance Specialist for Bioanalytical Data and Lab Systems will play a critical role in ensuring compliance with policies, quality standards, workflow procedures, and regulatory and accreditation requirements. This position will be responsible for conducting quality compliance audits of scientist/engineer records and lab systems, maintaining detailed auditing records, preparing trending reports, and monitoring auditing results to support optimal data integrity and continuous innovation and compliance.
 
Quality Compliance Audits:

• Conduct audits of scientist/engineer records to ensure completeness, accuracy, and appropriateness, including comparing source data to the records for accuracy and analyzing select data in detail.
• Audit department records and processes related to the bioanalytical data and lab systems, such as feedback surveys, after action reviews, and lab documentation.
• Prepare records for audits performed by other staff, such as supervisor reviews, project reviews, and internal audits.
• Identify opportunities for improving the quality and efficiency of records and processes.
• Participate in the preparation, facilitation, and follow-up activities for regulatory and accreditation surveys.
• Audit department records and processes related to general department functions, including training records, timekeeping, policy management, lab development plans/assessments/activities, and regulatory records.
• Complete audits according to an established schedule and procedures.
• Maintain detailed auditing data, including workload details and documented findings, recommendations, and corrections, for analytics.
• Inform and educate staff about audit findings, recommendations, and corrections.
• Report audit findings, recommendations, and corrections to internal leadership and complete follow-up activities as directed.
• Monitor and follow up on requested audit corrections to ensure completion.
• Develop audit and documentation/recordkeeping policies, procedures, and workflows.

 
Quality Compliance Analytics

• Utilize tools, systems, and methods to organize and catalog various auditing data.
• Perform data and statistical analysis on auditing data to generate metrics and other tracking and trending analytics.

 
Department Support

• Participate in performance improvement projects.
• Collaborate with other quality assurance positions within the organization.
• Participate in department committees, teams, and workgroups.
• Serve as a backup for quality and regulatory staff duties.
• Complete ongoing training and professional development.

 
Education:

• Bachelor’s Degree or higher in a science-based, quality, or engineering discipline
• Formal Quality Training including statistical process control or quality related qualification a plus.

 
Qualifications:

• A minimum of three years of professional experience in industry.
• Strong knowledge and hands-on experience working with quality management systems, standards, and regulations relevant to the industry, such as Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
• Proficiency in performing laboratory inspections, audits, investigations, root cause analyses, and corrective actions.
• Experience working with testing procedures, quality metrics, and statistical analysis.
• Familiarity with document control, change control, and risk management processes.
• Experience collaborating with cross-functional teams to ensure compliance and continuous improvement.

 
Skills and Competencies:

• Attention to detail when reviewing technical and other documentation for accuracy and completeness to ensure adherence to established standards and protocols; ability to ‘read for meaning’ and identify basic non-compliance issues.
• Strong analytical and problem-solving skills to identify, analyze, and resolve quality issues.
• Effective communication and interpersonal skills to work collaboratively with teams and stakeholders, and to provide clear and concise reports and documentation.
• Proficient in using tools to document and track quality data.
• Excellent written and verbal communication skills and the ability to positively influence others.
• Computer skills: High level of proficiency Excel, Word, Power Point, Outlook, LIMS
• Possess a sound and logical approach to problem solving.
• Must have good collaboration skills with team and stakeholders.