Pharm-Olam, LLC

Senior Quality Assurance Auditor (Remote - in or near Texas or North Carolina)*

Job Locations US-TX-Houston | US | US-NC-Raleigh-Durham
Job ID
2020-2435
Category
Quality Assurance

Overview

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.

 

Summary:

 

The Senior Auditor will have an in-depth understanding of Clinical Trials and Clinical Development, combined with an in-depth knowledge of ICH-GCP, appropriate GxP compliance standards, other international GCP regulations / standards (e.g. as applicable: EU Clinical Trial Directive and Regulation 536/2014 when effective, US FDA Code of Federal Regulations) and, as required/ applicable, local relevant GCP guidance, laws and regulations and appropriate processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors. The auditor will promote compliance with relevant GXP standards, international and local laws and regulations within the company and maintain behaviours which support: accountability, timeliness, transparency and consistency set a good example to others.

Auditors must be detail oriented, able to understand business needs and able to translate them in the daily work and responsibilities, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and able to manage confidential information appropriately. The Senior auditor will contribute to the execution of the QA audit schedules as assigned, performing internal and client contracted/billable audits, providing GxP and quality consultancy to internal/external clients where appropriate and will  facilitate client audits and/or assist with regulatory inspections, as assigned.

 

This is a full-time, direct hire role for an experienced Senior QA Auditor with GCP & CRO experience. Position can be home based, however, candidate must reside in or near Texas. Candidates must be open to travel (exceptions in place during covid-19 pandemic / audits are case by case basis) and have experience with remote audits & face to face audits. Auditors typically complete 2 audits monthly. #LI-Remote

Responsibilities

AUDITING

Independently plan, perform, report and follow-up on GCP audits across all phases and based on experience; with minimal supervision, plan, perform, report and follow-up on a range of GXP audits including system, vendor and project audits per client requirements and Pharm-Olam standards. 

Lead or participate in co-audits with Pharm-Olam client representatives, subject matter experts and other QA team members. 

Ensure findings and issues raised from audits/inspections and escalations are appropriately investigated, followed up and closed on time. 

Closely cooperate with Vendor Management function for vendor audits. 

Maintain a current passport and travel internationally for audits and other QA related activities.

 

QUALITY MANAGEMENT SYSTEM

Maintain and regularly update QA tools including eQMS and other systems with accurate information on quality and audits.

Development and maintenance of QA audit programs, as assigned. 

Assist the development, maintenance, and improvement of Pharm-Olam standards, procedures, systems and tools. 

Support the identification and assessment of QA department risks, and assist the development of risk control mechanisms, measures and reports. 

Help to identify company and departmental risks, and assist operations and management in risk analysis and development of risk control mechanisms and measures. 

Assist gap analysis and escalate or assist escalation, investigation and follow-up of quality issues including effectiveness checks.

 

CLIENT AUDIT & INSPECTION MANAGEMENT

Facilitate client audits and mock inspections, assess audit readiness and assist the preparation of internal teams. 

With minimal supervision facilitate regulatory inspections, support inspection training and preparation of internal teams and undertake inspection readiness activities, as assigned. 

Review and agree responses to sponsor audit and regulatory inspection reports/findings and trace the follow-up of findings/issues and their documentation within Pharm-Olam’s eQMS.

 

TRAINING

Maintain current working knowledge and expertise of Pharm-Olam controlled documents, standards, of GXP guidance and regulations, national and international regulations. 

Support and perform training and supervision of more junior auditors. 

Closely cooperate with training function for company training on quality topics; develop and deliver departmental or company training, as assigned. 

 

OPERATIONAL CONSULTANCY

Maintain a good working relationship with internal and external clients and provide advice on regulatory and GxP requirements and quality related topics for internal and external clients locally and globally. 

Liaise with external industry and regulatory inspectorate contacts and networks to learn about best practice on implementation of GXP requirements to inform internal clients and management. 

Closely cooperate with Therapeutic Area (TA) Heads maintaining QA/ Quality oversight and support function for Tas.

 

QUALITY REPORTING

Assist in the production and analysis of quality metrics, reports and Quality/Key Performance Indicators. 

Provide input on the Pharm-Olam QA audit strategy and audit schedules. 

With appropriate supervision and based on experience assist the review and approval of quality related documents and validation reports.

 

FUNCTIONAL TRAINING

Within Quality Assurance, individuals are expected to:

  1. 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; Quality audits; Pharmacovigilance; Clinical and scientific topics relevant to clinical trials; other topics connected to duties to be performed.
  2. Perform any necessary and specific training in trials.

To maintain at least 12 days of auditing annually, even if performing autonomous trial audit activities prior to 15 July 1997.

Qualifications

  • Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.).
  • Minimum experience of 4 years in a GCP role.
  • Minimum of 4 years experience as an autonomous Clinical Quality Assurance Auditor with experience in phase I-III audits, late phase and observational study audits, vendor and system audits and with experience in GCLP, GMP audits and ideally PV experience on joining.
  • Ideal to have experience working with US government contracts
  • Experience in hosting sponsor audits, and regulatory inspection experience
  • CRO experience preferred
  • Thorough knowledge of ICH/FDA/GCP Regulations/Guidelines and EU Directives and regulations.
  • Excellent communication, interpersonal and leadership skills, with attention to detail
  • High degree of flexibility and ability to adjust to changing priorities and unforeseen events
  • Ability to execute strategy and plans and to manage multiple and varied tasks, and prioritize workload
  • Experience with Microsoft based applications
  • Excellent organizational skills

For Consideration: 

 

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.

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