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Compliance Specialist

2 months ago

Lower Gwynedd Township, United States AllSTEM Connections Full time

AllSTEM Connections is seeking a Compliance Specialist to work onsite in Lower Gwynedd, PA.


This is a 12-month contract position. Possible extension/temp-to-hire.


Our confidential client is a global pharmaceutical company.


Hourly rate is up to $32.50


M-F, 8AM - 5PM.


Summary:

Our client is seeking a Quality Compliance Specialist for Bioanalytical Data and Lab Systems who 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.


Responsibilities

• 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.

• 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.


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.


Preferred Experience & Skills

• 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