Quality Control Analyst - I

QC Analyst -1 performs routine testing & water for chemical tests, organizing the inventory of lab supplies and any other assigned task. Maintains a working knowledge of current

GMP & GLP

compliant regulations for the Quality Control laboratory. Job Responsibilities Ø Preparation of SOPs, Specification, Standard testing procedure, Method of Analysis etc as per requirements Ø Sampling of raw materials and packing materials Ø Collect raw material, in-process, and finished product samples as per SOP. Ø Prepare reagents, standard solutions, and test samples for chemical analysis. Ø Perform routine chemical tests such as assay, purity, pH, loss on drying, moisture content, etc. Ø Conduct QC testing e.g. titrations, spectrophotometry (UV/IR), and other instrumental analyses as and when required. Ø Test water samples (e.g., purified water, WFI, pure steam) for chemical parameters. Ø Record test results accurately in laboratory notebooks. Ø Maintain all analytical data, logbooks, and test reports according to GMP/GLP standards. Ø Ensure timely reporting of any out-of-specification (OOS), Out of Trend (OOT), Lab event / lab incident or deviations to the supervisor. Ø Operate laboratory instruments (UV, IR, balance, pH meter, etc.) properly. Ø Perform routine calibration, maintenance, and troubleshooting of analytical equipment. Ø Follow all SOPs, GMP, GLP and safety guidelines strictly. Ø Participate in internal audits and assist during external inspections. Ø Participate in analyst qualification program (if required) Ø Maintain the stability samples and testing of stability samples as per SOP. Ø Maintain the retain samples of raw materials as per SOP. Ø Ensure all test methods comply with pharmacopeial standards (USP, BP, EP, any other any other regulatory / pharmacopeia standard). Ø Prepare, label, and maintain inventory of reagents and standard solutions. Ø Check expiry dates and ensure proper storage of chemicals. Ø To perform the risk assessment of Quality control related instruments Ø To prepare the Certificate of Analysis (COA) Ø Maintain a clean, organized, and safe working environment. Ø Follow chemical handling and waste disposal procedures. Ø Support method validation, verification, and analytical improvement projects. Ø Participate in training sessions for new analytical techniques and updates. Benefits Ø Competitive Salary/Hourly Rate Ø Medical, Dental, Vision Insurance Ø

Paid Time Off & Holidays Physical Demands:

• Required to stand, walk, sit, talk and hear; required to use hands to operate vehicles and office equipment; must be able to occasionally lift and/or move up to 50 lbs; specific vision requirements for this job include: close, distance and peripheral vision, and the ability to adjust focus, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position without compromising patient care. • KriGen Pharmaceuticals is an equal opportunity employer. All employment decisions are made without regard to age, color, race, ancestry, national origin, disability, genetic information, military status, religion, creed, sex, pregnancy, childbirth, marital status, citizenship, sexual orientation, gender identity, gender expression, legally protected medical condition, or any other basis prohibited by applicable law. Background checks and drug screens are part of our hiring process. Affirmative Action/Equal Opportunity Employer, Minority/Female/Disabled/Veteran.

Benefits:

Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person