Job Description

The QC Analyst is responsible for the day-to-day sampling and inventory in the QC lab and related duties. All duties performed in compliance to established regulatory, compendial, and internal quality standards for supporting Validation and Stability, and maintaining lab equipment, instruments, and inventory. The QC analyst works closely with the Quality team members, QC Manager, and Quality Assurance in all aspects of quality systems compliance and constant improvement.

Responsibilities

· Perform HPLC, GC, etc. sample preparation and testing

· Review, interpret, analyze and report data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines

· Clean, maintain, and troubleshoot instruments

· Perform compendial monograph testing and Garonit specific tests

· Assist in developing and validating non-compendial testing as needed

· Ensure lab safety and manage chemical inventory

· Train and develop other chemists

· Audit work of other chemists

· Daily balance and pH calibration

· Filing COAs, purchasing documents, receipt records, etc.

· Log in all incoming samples

· Manage Chemical Inventory and Waste Management/Disposal

· Prepare Samples for Customers, Contract Lab testing, and Stability

· Manage QC Sample and Retain Inventories

· Sample and test incoming raw materials, in-process , and finished product and packaging materials

· Perform compendial monograph testing and Garonit specific tests

· Perform wet chemistry tests following procedures and methods as required

· Work with Contract Laboratories and Service Providers

· Support Laboratory Investigations, all Investigations, CAPA, Change Controls, Validations, Stability Programs, APR, statistical analysis, environmental monitoring of air, water, and surfaces, as needed.

· Water sampling and microbial swabbing

· Complete all GMP logs, documents, and forms.

· Clean glassware.

· Assist in developing and validating non-compendial testing as needed

· Perform all other testing that may be required

· Perform additional laboratory duties as needed

· Other duties assigned by Management.

Qualifications

· Bachelor’s degree in a scientific or technical discipline (Chemistry preferred) with a minimum of 1 year experience in an FDA regulated laboratory.

or

Associates degree in a scientific field (Chemistry preferred) with a minimum of 3 years’ experience an FDA regulated laboratory.

Experience Preferred

· Experience working in an FDA regulated environment 

· Knowledge of USP Monograph testing

· Knowledge of CFR & ICH Regulatory Guidelines

· Knowledge of cGMP processes and lab safety

· Knowledge of HPLC, GC and Waters Empower a plus

Other Requirements

· Has excellent oral and written skills

· Has excellent interpersonal skills 

· Is self motivated

· Has a very high attention to detail

· Has a positive attitude

· Must speak, read and write in English

· Able to lift 25 pounds

· Able to stand for extended periods

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