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
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
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
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
Report findings to the Study Director/Management; monitor corrective actions.
Write, review, and distribute SOPs
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 $
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.
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
Because of the ever-tightening government regulations on the manufacturing drugs
the need for QA specialists is increasing.
for Quality Assurance Positions