Senior Quality Assurance Associate
This position is a Senior Quality Assurance (QA) Associate, responsible for supporting quality assurance objectives for GxPs (GCP, GLP, GCLP, GMP) and CAP/CLIA. Under the direction of the Manager of Quality Assurance, this position’s primary role will be to maintain and monitor compliance of DxTerity’s Clinical Laboratory and Clinical Study services.
As the Sr. QA Associate, this position supports the clinical laboratory and clinical study quality management programs; maintain and manage quality policies and procedures; facilitate internal/external quality audits; report to management on the performance of monitoring results and corrective/preventive actions; work with the lab/study personnel to resolve quality issues/deficiencies; conduct quality investigations and perform root cause analysis; maintain accurate and complete documentation in compliance with regulatory requirements; escalate issues as appropriate to Management.
All work performed in this role will be in compliance with local, federal and state regulations including GCP (21 CFR 50), GLP (42 CFR 58), GMP (21 CFR 820), CAP/CLIA, and applicable standards, such as ICH GCP and EN ISO 13485:2016.
- Assist QA management in the development and implementation of procedures and working practices to ensure continuous quality improvement.
- Conducts training of personnel on quality standards and procedures.
- Support the maintenance of training programs, policies and procedures.
- Provide support in the identification of training gaps.
- Work with stakeholders to develop and execute strategic internal audit plans.
- Schedule, prepare and conduct internal audits against approved procedures and statutory/regulatory requirements.
- Vendor audits including, but not limited to, CROs, Central Labs, IRBs, and Data Management.
- Prepare audit reports in a timely manner; identify any failure to meet the standards and address any issues with DxTerity Management.
- Track implementation of corrective actions related to audit findings, including verification of effectiveness.
- Manage distribution and archiving of audit reports and findings.
- Supports regulatory inspections activities (as applicable), including taking notes and assisting in the preparation, coordination, and tracking of document/record requests, responses, and any supporting documentation; implementation of remediation after inspections.
- Assist in resolving compliance issues and provide assessment of the impact of any deficiencies.
- May lead or assist with investigations to determine root cause analysis and ensure that effective corrective action plans are put in place.
- Administer the CAPA Program and appropriately escalate any compliance risks to management.
- Interprets standards and regulations, evaluates impact and potential compliance risks.
- Stays informed of updates to applicable regulations, guidelines, and principles and advise the company on their use and compliance.
- Review of documentation/records for accuracy, completeness and to ensure good documentation practices are followed.
Expertise: Knowledge & Skills
- Knowledge and experience of Quality Systems and regulatory requirements for GxPs and other applicable regulations and laws (OSHA, HIPAA).
- Good knowledge of international regulatory requirements and industry guidelines governing global GCP and GLP (ICH/FDA) and an ability to interpret and enforce regulatory requirements.
- GCP/GLP Auditing Experience A MUST
- Knowledge and experience of other GxPs (GMP) preferred
- Experience with registrations, accreditations or certifications preferred
- Experience with CAPA and Risk Management processes.
- Experience in Training, Competency and Proficiency Testing.
- Experience writing and executing work instructions, protocols, and procedure.
- Exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information.
- Able to develop strong working relationships with all functions of the company, such as, Operations, R&D and Product Development.
- Must possess strong team skills and be results-oriented.
- Strong analytical and problem-solving skills.
- Able to deliver quality outputs under deadlines.
- Excellent written and verbal communication and interpersonal skills.
- Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages and validation requirements.
- Bachelor’s degree in Science or related technical field required.
- 3+ years experience Quality Assurance working in a CLIA/CAP laboratory.
- 2+ years direct experience in site management and logistical execution of clinical trials within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
- Working knowledge of federal, state and local laboratory and clinical study regulations.
Physical Demands Work entails regularly performing tasks in a laboratory environment and while working at a computer and/or desk. Work entails occasional lifting and/or moving up to 25 pounds. The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may occasionally be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and moderate levels of noise and vibration.