Quality Assurance Specialists

QA Job Description

In the industry, quality control and assurance play an important role. Various tools and methods are employed to ensure that drug products comply with high standards of purity, safety, potency and quality to meet stringent regulations and customer demand.

Traditional definitions of Quality Assurance are appropriate for the biotechnology industry. Standard systems and methodologies become the core for the function. Any organization must understand not only the role of the Quality Assurance function but also 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 the R&D area. A Quality Assurance Specialist must understand his/her 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. A Quality Assurance Specialist must take a positive, active role in this definition. There is absolutely no other way to guarantee that the end product is ready 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.

Ensure implementation of good laboratory (GLP), good clinical practices (GCP) and/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 discrepancies identified during routine operations monitoring and process testing in a timely manner to a 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), GMPs (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 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 USD

Typical salaries with 3 and more years of experience range from $65,000 to $ 95,000 USD

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, and 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 


Quality Assurance

Engineering
Chemistry
biochemistry;
Computer Sciences
Pharmaceutical ;
biology;
biomedical science;
Business Administration
microbiology;
medicine;
molecular biology;
pharmacology;


Because of the ever-tightening government regulations on the manufacturing drugs the need for QA specialists is increasing.

Application for Quality Assurance Positions