Quality Control Inspector

Responsibilities:Learn SOPs, safety procedures, and QC methods.Assist with IQ/OQ/PQ of new equipment; collaborate with field engineers.Draft/review SOPs, forms, FMECA, tech transfer protocols, and validation protocols.Perform QC testing for batch release within hours of production.Continue Setup Phase tasks; adhere to SOPs, cGMP, and regulatory requirements.Follow EHS regulations, including NRC, OSHA, and EPA guidelines.Maintain readiness for inspections and ensure qualification for all QC procedures.Verify instrument calibration/qualification.Confirm raw materials are not expired and perform system suitability testing.Conduct QC testing for chemistry, microbial, EM, and sterility.Complete and review documentation; troubleshoot equipment and report issues.Assist with material handling, QC lab maintenance, waste disposal, and employee training.Draft/review SOPs, assist with quality events, and support equipment qualification/method validation as needed.Qualifications:Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.Minimum of 2 years in Quality Control, including at least 1 year working with 21 CFR Parts 11, 210, and 211.Proficient with analytical instruments, HPLC, USP methods, ICH guidelines, and GMP practices.Solid grasp of GMP, FDA, and regulatory standards.Demonstrates high integrity and honesty, with a strong adherence to rules, policies, and regulations.Capable of managing multiple tasks effectively under pressure and tight deadlines.Detail-oriented with excellent organizational skills.Ability to stand for extended periods (6+ hours).