Thursday, April 07, 2005

The role of Quality Assurance Specialist in the biotechnology industry

Kriger QA Training: Quality Assurance Program , ,

This article has been published by the International Biopharmaceutical Association

The project is sponsored by KRC CRO and training services ( ) and ClinQua CRO ( )

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The traditional definitions of Quality Assurance are appropriate for the biotechnology industry. The standard systems and methodologies become the core for the function. The organization must understand not only the role of the Quality Assurance function but the responsibilities of the organization toward product quality. The Quality Assurance function establishes the systems, but everyone has a responsibility for quality. Quality must begin in me R&D area. Quality Assurance Specialist must understand its role and how he/she relates to the mission of the company. The ongoing process of the biotechnology manufacturing atmosphere makes it important to define the product by the process. Quality Assurance Specialist must take a positive, active role in this definition. There is absolutely no other way to guarantee the end product "fitness for use".
The role of Quality Assurance Specialist in the biotechnology industry is complicated by the process methodology and the need to define the product by the process. The systems and the support activities are the key elements to this definition. The validation of all aspects of the process becomes the Quality Assurance of the material. The means for determining the safety, efficacy, purity, and stability of the end material are related to this process definition.
Typical Work Activities
Typical work activities include :
Ensure timely completion of routine QA procedures, manufacturing, packaging and Formulation Development in-process testing checks, sampling and other agreed upon duties and / or ensure implementing of good laboratory (GLP) , good clinical practices (GCP) or good manufacturing practices (GMP) (emphasis depends on employer's requirements and type of employer).
Ensure timely inspection, sign in and reconciliation of production rooms, equipment, raw materials and packaging components.
Report any non-conformances that are identified during routine operations monitoring and in-process testing in a timely manner to QA Supervisor and provide assistance in the Quality Notification investigation.
Ensure that of all phases of manufacturing, packaging and Formulation Development comply with relevant SOPs (Standard Operations Procedures), cGMPs (Good Manufacturing Practices) and safety guidelines.
Perform SAP transactions for various tasks completed to ensure that status of raw materials, packaging components, semi-finished products are correct both physically and electronically.
Participate as a member of the Quality Assurance Dept., to develop, implement and conduct in-process quality inspections through the manufacturing and packaging facilities .
Assist in the development and execution of inspection systems that will track and report on production compliance metrics.
Communicate quality assessments (e.g. deviation trends, batch record reworks, audit findings, etc) and assist as a member of Quality Assurance to coordinate required corrective actions.
Review procedures and processes for accuracy, completeness and to ensure revisions are processed in a timely manner
Participate as a representative of the Quality Assurance Inspection Team as required for special cross-functional departmental meetings and/or committees
Auditing the Bioanalytical Laboratory for compliance with FDA GLP and other applicable regulations
Report findings to the Study Director/Management; monitor corrective actions.
Write, review, and distribute SOPs
Work Conditions
Typical starting salaries range from $ 45,000 to $ 65,000
Typical salaries with 3 and more years of experience range from $65,000 to $ 95,000
Salaries vary quite widely from company to company. Bonuses may be paid.
Working conditions vary between companies. You will need to work extra hours sometimes, although weekend or shift work is uncommon.
Entry Requirements
Knowledge of GLP, GCP, GMPs is a must. Excellent organizational and interpersonal skills. Prior experience in the pharmaceutical industry is preferred. Computer literacy - general word processor/database software. Excellent verbal and written communication skills. Good interpersonal skills/team player. Ability to assess and identify GMP and quality-related issues. Strong attention to detail. Demonstrated time management skills and the ability to work toward deadlines is required.Experience/familiarity with Therapeutic Product Directorate (TPD) and Food and Drug Administration (FDA) regulatory requirements.
University degree, preferably in
Computer Sciences
Pharmaceutical ;
biomedical science;
Business Administration
molecular biology;
Because of the ever-tightening government regulations on the manufacturing drugs the need for QA specialists is increasing.

Quality Assurance & Regulatory Affaires, ICH GLP, GCP, GMP Guidelines Professional Development Program is designed for Bachelor / Master (or PhD) Degree in Engineering, Business Administration, Computer & Information Technology, Bachelor of Science in Business / Management , Chemistry, Biochemistry, Pharmacology and other BSc degrees.
This course is intended to give both general and specific information and guidelines to help establish, develop, and implement Quality Assurance in a biopharmaceutical manufacturing environment. This program is designed to provide a focused course of study for individuals seeking to position themselves for pharmaceutical and biotechnological industry as a quality assurance auditor, validation specialist or regulatory affairs officer. It will also provide knowledge and skills of excellence Good Laboratory, Clinical and Manufacturing Practices. This course provides a comprehensive overview of the roles/responsibilities of both the quality assurance auditor, validation specialist or regulatory affairs officer in pharmaceutical industry. This program was created to provide you with the key aspects, differences, challenges, job criteria and demands, and industry expectations. Course content will focus on key concepts and information essential to effectively function in the pharmaceutical / biotechnological industrial arena. This course can open doors to new and exciting career opportunities in quality assurance as the demand for qualified and trained specialists is still growing.
The development of the biotechnology, or "biotech", industry for biopharmaceuticals is exciting and rapid. Many new, small companies have been, or are being, established. The main emphasis of these companies is the development of the science associated with their particular products. There is a tendency to develop the science and leave the quality function in the background. For the ultimate success of the company, it is important to start developing the QA function in parallel with the science.

We would like to highlight once again the benefits of your enrolment in this program:
1. You get the essential knowledge of everything you need in order to apply for Quality Assurance Positions. Along with in-class sessions you get free access to Interactive Training Programs On-line. You have complete coverage of all materials needed. Upon completion of this program you will pass on-line final exams and receive by mail or in person Diploma stating your new qualifications.
2. You receive a specially designed Diploma stating the program objective: “The International Conference on Harmonization (ICH): "Good Clinical, Laboratory, Manufacturing Practice (GCP, GLP, GMP) Guidelines, Quality Assurance & Regulatory Affaires in Pharmaceutical Industry”. This is essential in requirements to any position of Quality Assurance. (Look at the positions on our site or in our Newsletter - you will see that all of them require this knowledge).
3. You participate and gain unique experience in real Practical Projects.
4. You get reference letters on your project participation adjusted to your needs and reflecting all appropriate details of your active participation in full-scale practical projects. Without proper reference letters it is completely useless to approach any serious Pharmaceutical Company in order to get a job.
5. You get perpetual support of our research centre staff when you mention our institution in your resume as a place where your potential employer could obtain references. Almost always, prospective employer would make a call to collect references in personal phone conversation.
6. When your prospective employer will call us for reference, we would reflect all the details of your research participation and appropriate qualifications. This could drastically increase your chances to get a job .
7. You get active help in your resume editing. Remember, your resume is the first step to get a job. Now you would include into your resume as last entries, your participation in GCP, GLP, GMP Guidelines, Quality Assurance & Regulatory Affaires in Pharmaceutical Industry seminar and US / Canadian Experience in Real Project at Kriger Research Center Inc.
8. You will get return on your investment in your education and training at KRC at least at 40 times more then you have paid and this in very first year of your work in Quality Assurance.

Please direct all your questions to or call us at (866) 757-9791 (USA and Canada) or + 1(416) 630-0038 (Internationally)