Industry Pharmaceuticals Work Experience 5+ years
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies with services designed to help achieve regulatory compliance requirements.
PSC Biotech Corporation serves over 350 clients in more than 23 countries through professional services consulting, cloud-based software solutions, and pharmaceutical contract manufacturing.
PSC Biotech Corporation has three unique active divisions within the parent company, each representing one of our areas of expertise : PSC Biotech™, PSC Software™, and BioTechnique™.
Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
PSC Biotech Corporation is seeking a Quality Assurance Auditor - GLP. The successful candidate will have quality assurance expertise within a GLP environment.
Role : The role of the Quality Assurance Auditor is to assess and assure study, project and process compliance with protocols, Controlled documents, and applicable regulations and guidelines through audits.
Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports;
and determine acceptability of the responses and verify the corrections (includes but not limited to Study Source Data Audits, Trial Master File audits, Database audits, Clinical Study Report audits).
Conduct GLP Audit, generate product audit findings and report, develop a CAPA resolution report.
Perform in-process inspections of study phases and methods; report audit findings to operations via QA audit reports; determine acceptability of the responses and verify the corrections.
Review deviations, investigations, and change control documentation; and assess acceptability of the content and documentation.
Maintain QA files and QA audit reports.
Interact with internal and external clients to discuss QA observations and study-related issues, and maintain effective and professional working relationships within and across departments in relation to study projects.
Perform other functions as assigned by Quality Assurance Management.
Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports;
effectiveness and efficiency of the processes.
Detect Quality Issues and the need for CAPAs and assist Quality Assurance Management with the QI / CAPA process
Assist with the preparation for and hosting of client audits and / or regulatory inspections.
Participate in the preparation, execution and follow up for System Audits, Vendor Audits, Site Audits.
Bachelor’s degree in a science degree program
8+ years quality / functional operations / GLP experience highly preferred, but not required
Working knowledge of applicable Clinical, Data Management and External Site Services function regulations and guidance (GCP / GLP / cGMP / GDP E-records & E-signatures) regulations and related guidelines
Excellent oral and written communication skills
Ability to organize and manage multiple priorities
Excellent time management skills
Attention to detail, tactful, and diplomatic
Proficiency with Microsoft Office and general computer knowledge.
This is a remote position.