Quality assurance associate
Quality assurance (QA) associates work to ensure that biotechnology products meet all the quality attributes — safety, efficacy, potency and purity — required by customers and regulatory agencies. Whether a particular product is going to be consumed by people and animals or distributed into the environment, QA associates validate that these products comply with all product label claims and regulatory filings. Also called quality assurance auditors and quality assurance specialists, QA associates maintain the quality systems, such as laboratory control, investigation management, materials management, document control and training to ensure control of the manufacturing process.
Nearly all biotech firms employ QA associates to review good manufacturing practices (GMP) documents. GMPs are manufacturing guidelines and legal regulations put forth by the FDA to ensure the safety and effectiveness of drug products and medical devices. GMPs only define the required outcome, not how work is to be performed, so each organization is free to choose how to achieve the end product. QA associates work to review company procedures for compliance with GMP documents, spending a significant percentage of their time assessing discrepancies from procedures and reviewing GMP raw data for compliance. QA associates also are involved in the review and approval of GMP procedures as well as the preparation of measurement standards for quality compliance.
Most companies employ several QA associates who collaborate across projects and who work regularly with other internal organizational units, under the supervision of a QA manager to ensure compliance with applicable regulatory requirements. Individuals with strong interpersonal, analytical and organizational skills will be well-suited for the position’s activities. Associates should be able to understand and interpret written material as well as explain those materials and new regulations to team members and employees. Associates conduct audits; training programs; data and documentation reviews; and analysis. Some associates write and revise standard operating procedures and related manufacturing documents. Documentation is a large part of the QA associate’s job and vital for his or her organization.
Many biotech firms have four levels of QA associates that require increasing skill levels. With experience and demonstrated success, associates may advance into these positions and work towards becoming the organization’s QA manager.
QA positions are open to individuals with a variety of education and training backgrounds. Detail-oriented individuals with excellent communication skills and experience in the biotech industry may secure a job with only a high school diploma. However, obtaining a position as a QA is more common for graduates of a four-year college with a degree in the life sciences or engineering and minimal industry experience. Most companies offer on-the-job training. The number of programs offering master’s degrees in QA and Regulatory Science is increasing as well.
The general entry-level salary range for a validation specialist is $40,000 to $50,000 per year. Salary information is current as of April 2010.