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Quality Control Analyst
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$64,764 / year median in the U.S.
-13% projected decline
Job Description
Job Title:
Quality Control Analyst Job Description The Quality Control Analyst works onsite in a GMP-regulated laboratory, performing raw material and product release testing to ensure that all samples meet established quality requirements. This role is available at multiple levels (I, II, or III), with level determined by the depth of experience. The analyst conducts chemistry-based testing, documents results in accordance with regulatory and corporate standards, and supports continuous improvement initiatives within the QC function. Responsibilities Perform raw material compendial chemistry testing for quality control samples in a GMP environment. Conduct product testing related to chemistry methods for quality control samples, ensuring accuracy and reliability of results. Execute GMP testing and associated laboratory tasks without errors, strictly following applicable standard operating procedures (SOPs) and protocols. Ensure all samples are tested according to established quality requirements and that reported results are valid, accurate, and fully documented. Comply with procedures designed to maintain adherence to legal regulations, health and safety standards, and regulatory requirements. Apply data integrity principles to all laboratory activities, ensuring that records are complete, consistent, and traceable. Participate in 6S lean lab operations to maintain an organized, efficient, and safe laboratory environment. Support preventive action and continuous improvement programs aimed at reducing costs and enhancing laboratory efficiency. Use laboratory information management systems (LIMS) to enter, manage, and retrieve test data and results. Operate analytical instruments and perform hands-on analytical testing in accordance with analytical methods and compendial standards. Essential Skills Bachelor's degree in a scientific discipline. Knowledge of Good Manufacturing Practices (GMPs) and their application in a laboratory environment. Strong understanding of laboratory documentation requirements and data integrity principles, including ALCOA. Experience with hands-on analytical testing and familiarity with analytical methods and related instrumentation. Experience using laboratory information management systems (LIMS), including GLIMS Labware. Experience testing with pharmaceutical compendia (USP/EP) or strong knowledge of compendial requirements. Ability to follow SOPs and protocols precisely and perform GMP testing without errors. Attention to detail and ability to generate accurate, valid, and compliant test results. Additional Skills & Qualifications Understanding of GMP principles and their impact on product quality and regulatory compliance. Understanding of ALCOA data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate). Experience working with compendial testing standards such as USP and EP. Familiarity with 6S or lean laboratory practices and participation in continuous improvement initiatives. Ability to work collaboratively in a QC team environment and communicate effectively about test results and laboratory issues. Strong organizational skills to manage multiple tests and documentation requirements in a regulated setting. Work Environment This is a fully on-site laboratory role, working Monday through Friday from 8:00 a.m. to 4:30 p.m. The position is based in a GMP-regulated quality control environment that uses analytical instrumentation and laboratory information management systems such as GLIMS Labware. The work involves routine handling of raw materials and product samples, adherence to health and safety procedures, and participation in 6S lean lab practices to maintain a clean, organized, and efficient workspace. The environment emphasizes regulatory compliance, data integrity, and continuous improvement within a structured, team-oriented setting. Job Type & Location This is a Contract position based out of Holly Springs, NC. Pay and Benefits The pay range for this position is $25.00 - $30.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Holly Springs,NC.