Quality Control, commonly abbreviated as QC, is the practice of ensuring consistent quality throughout a manufacturing process and also uniformity in a company’s products.
Quality control analysts in biotechnology may work in offices or laboratories, depending on the employer, and high-security measures are occasionally required in their facilities to protect proprietary or sensitive information. These high-level facilities often require intense screening, and companies often have strict security demands and qualifications for this position.
A QC analyst performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. Conducts and validates various biological and chemical quality control (QC) assays. Compiles, interprets, and documents statistical data from testing processes to either confirm compliance with established quality standards or identify deviations. They are maybe responsible for establishing specifications for conducting assays and writing standard operating procedures. Typically requires a bachelor’s degree. Typically reports to a supervisor or manager. They work on projects/matters of limited complexity in a support role. They work under direct supervision. Typically requires 0-2 years of related experience.
The Quality Control Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability.
Quality Control Analyst, Biotechnology Tasks:
- Perform biological tests on raw materials as well as final products to ensure quality standards are met.
- Work with research team and upper management to ensure that quality standards are evenly enforced.
- Maintain accurate data and produce reports on biological tests.
- A QC Analyst focuses on testing substances for compliance to standards and requirements. This could be at the start of the production process (Raw Materials Analyst), during production itself (In Process Analyst) or at the end of manufacture (Finished Product testing).
A QC Analyst utilizes lab skills (chemistry usually, but could also include physical test methods, microbiology and other skills) to test and measure materials, generally in a manufacturing field such as pharmaceutical manufacturing, chemical manufacturing, and other industry sectors. A QC Analyst ensures that experiments are completed according to established Standard Operating Practices (SOPs), and also Good Laboratory Practices (GLP) or Good Clinical Practices (GCP) for highly regulated industries. Good Manufacturing Practices (GMP) is also adhered to for in process testing. Some QC Analysts are required to validate instrumentation and experiments as well.
- QC Analysts prepare and test samples from all phases of a manufacturing or other handling process, with the goal of determining if the substance meets the standards or requirements of the project.
- A variety of methods that vary from industry to industry but generally require basic lab-work skills and thorough understanding of chemical & pharma testing equipment and processes.
- They prepare technical documents that report the results of their lab work.
- They may also be responsible for minor equipment troubleshooting, calibration and repair.
- QC Analysts may need to have a degree or equivalent in chemistry or a relevant subject to the industry sector, such as pharmaceutical sciences or biochemistry.
- Via various Biotech industrial training, students will develop some necessary laboratory skills for fulfilling the duties required of an entry level QC Analyst, including knowledge of how to perform analytical chemistry, biochemistry, instrumental analysis and physical chemistry work.
- Most universities may also have options for students to undertake a placement year in industry – this is a great way of ensuring that you have practical skills relevant to the wider work place.
- A QC Analyst vacancy is an excellent role to begin a career in industry; you will be required to perform a variety of tasks which will provide you with a broad range of experience which can be transferred into any future positions.
- If you already have some industrial experience you may decide to move into quality to gain experience working in another industry or working environment.
Having a quality background may open doors into other areas of the business and there are other roles that can be progressed into in the Quality Department such as:
- QA Manager
- QA Auditor
- QC Supervisor
- Quality Assurance (QA) Officer
Gaining experience in a quality based role will be valuable for your career development especially if you manage to advance into QA, as these skills set is in demand.
Top companies for a QC job:
- Libra International Limited
- Sidmak Laboratories pvt ltd.
- Pidilite Industries Ltd.
- Wipro ltd.
- J. Mitra and Co. Pvt Ltd.
- Eagle Seeds And Biotech Ltd.
- Paragon Bioservices
- Arsh Biotech
- IPCA Laboratories
- Lupin Limited