Quality Assurance Officer

Overview

Transpharmation is a dynamic preclinical contract research organization that specializes in high-quality, translational drug discovery services. The company provides a friendly and team-oriented work atmosphere as well as competitive wages and benefits.

Job Summary

The Quality Assurance Officer (GLP) is responsible for ensuring that all Good Laboratory Practice (GLP) studies are conducted in compliance with regulatory requirements and company standards. This role involves conducting audits, reviewing documentation, and providing training to ensure the accuracy, integrity, and quality of study data. In addition, the Quality Assurance Officer is responsible for ensuring that all non-GLP studies are conducted in compliance with regulatory requirements and company standards which includes but is not limited to QC (Quality Control) of documentation, data spreadsheets, and procedures.

Responsibilities

- Compliance Monitoring: Conduct regular audits and inspections of studies to ensure compliance with regulatory guidelines and company SOPs. Perform facility inspections according to the OECD principles of GLP.
- Audit Reporting: Prepare detailed audit reports, documenting findings and recommending corrective actions to address any non-compliance issues.
- Documentation Review: Review study protocols, raw data, and final reports to verify accuracy and adherence to standards.
- Training: Provide training to study personnel to ensure they understand and comply with regulatory requirements and company procedures.
- Quality Assurance Activities: Develop and maintain quality assurance procedures and documentation, including SOPs, audit checklists, and training materials.
- Regulatory Liaison: Serve as a point of contact for regulatory inspections and audits, ensuring that all necessary documentation and records are available and up-to-date.
- Continuous Improvement: Identify opportunities for process improvements and implement changes to enhance the quality and efficiency of studies.
- Other duties as assigned

Interaction

This position will liaise with all other departments on an as needed basis.

Communication

Verbal communication is required to request and receive instructions for work, to report on activities, results, and problems. Written communication is required for accurate and detailed recording of procedures, and for completing documentation. Reading and comprehension of written procedures and manuals is essential.

Working Conditions

- ENVIRONMENT: This position will be within the office environment and includes sitting for extended periods of time.
- RISK TO HEALTH: There will be occasional periods of several hours per day performing physically repetitive procedures (typing, filing etc.). There is also a potential for digital eye strain resulting from prolonged computer use.

Physical Requirements

- PHYSICAL DEMANDS: Little to no physical effort required.
- PHYSICAL DEXTERITY: Visual acuity, agility, accuracy and consistency will be required.

Qualifications

- Education: Bachelor's degree in relevant scientific discipline (e.g., Biology, Chemistry, Pharmacology).
- Experience: Minimum of 3 years of experience in a quality assurance role within a GLP-regulated environment.
- Proven understanding of GLP regulations and guidelines.
- Excellent attention to detail and strong analytical skills.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office and quality management software.

Knowledge/Skills

- Experience in a CRO or pharmaceutical environment.
- Certification in Quality Assurance or related field.
- Familiarity with electronic data capture systems and laboratory information management systems (LIMS).

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