About Pharm-Olam, LLC:
Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.
To ensure the safety of patients and the integrity of data, QA function assures the conformance of activities with documented standards, Good Clinical Practice (GCP) and the applicable regulatory requirements.
Responsible for quality systems and operational quality within the Quality and Compliance function of the Pharm-Olam group of companies.
While maintaining awareness for Quality and Compliance activities, handling assigned areas of activity and acting as backup for others as qualified, which include: Quality Management Systems; Controlled Document Management; Inspection Readiness; Internal Auditing; Training; and Functioning as a QA representative.
Performs duties independently, whilst helping to improve process standards.
This is a full-time, direct hire role for an experienced QA Auditor, located in the United States. This is a home based role that can require travel as needed as needed (including some overnight travel). In normal circumstances, on average, QA Auditors can travel about 50% of the time, typically completing about 12-18 audits annually. #LI-Remote
The incumbent will manage, be responsible within or support within the areas of competence listed below:
Quality Management Systems
- Coordination of quality and compliance data, working to provide demonstrable operational and financial efficiencies through Practical Process Improvement (PPI) while maintaining and reinforcing compliance.
- Development and maintenance of Quality Assurance Audit Programs and acting as independent reviewer and approver of Quality Assurance Audit Programs.
- Creation of cases and corrective and preventative action plans (CA/PA), tracking, identifying trends, facilitating discussion and applying expertise in investigations and effectiveness evaluations, through to closure.
- Maintaining Quality Assurance risk assessment and management schemes including the creation and utilization of Quality Assurance key performance indicators (KPIs).
- Development and maintenance of project audit programs and for the review and approval of project audit programs.
Controlled Document Management
Supporting for the:
- Maintenance of controlled documentation system, guiding the review of SOPs and associated documents (and associated training) as elements of the Quality System for continuous improvement and ongoing compliance.
- Development and maintained of Quality Assurance Controlled Documentation and Training Materials
Inspection Readiness (IR)
Responsible for the:
- Planning, preparing, coordinating, hosting and agreeing responses of sponsor and regulatory inspections or audits at Pharm-Olam facilities or investigational sites.
- Preparing sites, functions and offices in their preparation for inspection or audit.
Internal Auditing (IA)
Responsible for the:
- Enhancement of worldwide clinical quality assurance programs to identify risk in the enhancement, creation and maintain individual audit plans.
- As qualified, provision as an autonomous auditor, of auditor service for studies, vendors, systems and documents to assure compliance with ICH, FDA, GCP Regulations and EU Directives, SOPs, and national/local guidelines. and acting as a qualified lead auditor in an audit team and supervising trainee and junior auditors.
- Reporting of audits, following up through CA/PA to closure and reviewing audit reports and recommending improvement strategies.
- Development and maintenance of role-based curricula, competencies and events
- Identification of training gaps, providing instructional design expertise, delivering educational events, providing performance and effectiveness evaluation; working with functional training coordinators and SMEs to facilitate the same.
- Assist the training and management of trainee and junior auditors.
- Delivery of training as assigned and qualified.
- To act as a QA representative in support of our Sponsors.
- To promote quality standards and awareness for all Company staff.
- Provide routine GCP/ QA consultation for all Company staff.
- To maintain behaviours which support: accountability, timeliness, simplicity and consistency.
- To update line management regularly on the level of compliance and quality opportunities. Maintaining and tracking appropriate key performance indicators
- To deliver on other related duties, responsibilities and tasks, performing a role in assisting line management, as required.
Within Quality and Compliance individuals are expected to:
- Keep up-to-date with relevant Regulations/Guidelines, and to provide internal training on them, where appropriate. Undergo at least 30 hours of specific annual refresher training on one or more of the following topics: Clinical trial methodology and legislation; GCP; GMP for the investigational medicinal product; Quality systems; Pharmacovigilance; Clinical and scientific topics relevant to clinical trials; other topics connected to duties to be performed.
- Perform any necessary and specific training in trials.
- If assigned to perform autonomous auditing activities, unless performing autonomous trial audit activities prior to 15 July 1997 to demonstrate:
- At least 20 days of auditing activities shadowing expert auditors in the 12 months prior to the start of autonomous auditing activities; at least 50% of which shall take place during visits at trial sites.
- At least 4 months of activity in the 12 months prior to the start of autonomous auditing activities in the sector of medicinal product or clinical trial control or vigilance; alternatively, a further 40 days of auditing as above; or 60 days activity as a CRA in the 12 months prior to the start of autonomous auditing activities; alternatively, attainment of a post-graduate university Master’s in clinical trials or in regulatory sciences or in equivalent disciplines, in the 36 months prior to the start or autonomous auditing activities.
- To maintain at least 12 days of auditing annually, even if performing autonomous trial audit activities prior to 15 July 1997.
- Minimum experience of 4-8 years in a GCP environment, ideally 2-5 years as an autonomous Clinical Quality Assurance Auditor with experience in other elements: inspection readiness, quality systems management, training will be considered.
- Preferred To perform autonomous auditing, a Bachelor’s or Master’s degree in a healthcare/ scientific discipline relevant to the activities to be conducted is necessary
- Thorough knowledge of ICH/FDA/GCP Regulations/Guidelines and EU Directives.
- Excellent communication, interpersonal and leadership skills, with attention to detail
- Requires travel and an up-to-date passport.
- Minimum experience of 3 years in a GCP environment, with at least 2 years as a Clinical QA Auditor or relevant experience.
- A thorough knowledge of ICH GCP and relevant European Directives/FDA guidelines and other national guidelines/regulations.
- Excellent communication and interpersonal skills.
- Ability to pay close attention to detail.
- Preferred, Unless exempt, at least 60 hours of theoretical training in the last 12 months on the following topics: Quality systems and Quality Assurance; Clinical Trial methodology and legislation; GCP; Good Manufacturing Practice (GMP), with specific reference to the investigational medicinal product; Pharmacovigilance.
Please apply online at www.pharm-olam.com/careers
Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.