QC Chemist

23h23 hours ago

Vantage Specialty Chemicals

Englewood, US · Full-time · $52,000 – $60,000

About this role

The QC Chemist creates methods as needed and verifies and validates pre-existing methods to establish Standard Operating Procedures for testing raw materials and finished good products. They maintain equipment and laboratory compliance for all used equipment. Solutions and standards are ensured to be made, available, and up to date while keeping the laboratory clean and safe for chemical handling.

QC lab analysis is carried out on raw materials, in-process samples, and final products to determine accurate results in a timely manner. Results are properly communicated to customers within the Quality System framework of ISO 9000, FSSC 22000/22002, and cGMP. This supports manufacturing operations and serves external customers with correct product quality and information.

Work is performed independently and in a team to handle tasks efficiently, complete shift hand-overs with full understanding of issues, and support production operators in testing. Full communication with internal and external customers ensures requirements and results are understood, with proper interpretation supplied. Contractors are trained and enforced to meet cGMP, GFSI, ISO, and food safety requirements.

Questionable results and equipment problems are spotted and troubleshot for timely resolution, keeping proper people informed. Small projects are suggested and run within QC Lab scope for improvements. Internal audits are conducted to ISO 9001:2015, FSSC 22000:2018, and GMP ICHQ7 standards, including investigations on out-of-specification results and customer complaints.

Requirements

Knowledge of ISO 9000, FSSC 22000/22002, and cGMP standards for food and drug products
Familiarity with USP monographs for drug testing
Internal audit certification to ISO 9001:2015, FSSC 22000:2018, and GMP ICHQ7 standards
Ability to conduct investigations on out-of-specification results, customer complaints, root cause analysis, and Corrective and Preventive Actions
Skill in reviewing documentation for accuracy, unapproved deviations, and compliance
Understanding of FDA and GFSI standards for reporting food/drug safety issues
Proficiency in method creation, verification, and validation for SOPs
Experience maintaining lab equipment calibration and compliance records

Responsibilities

Carry out QC analytical work exactly to required written methods using correct equipment for accurate, timely reporting to internal and external customers
Perform all work to ISO 9000, FSSC 22000/22002 standards applying cGMP food and drug safety with knowledge of USP monographs
Immediately report accidents, hazardous incidents, or food/drug safety concerns to management per FDA and GFSI standards
Comply, maintain, train, and enforce contractors to meet cGMP, GFSI, ISO, and food safety requirements for the site
Communicate fully with internal and external customers to ensure requirements and results are understood and properly interpreted
Work independently and in a team to support production operators, complete shift hand-overs, and keep lab manager apprised of issues
Spot and troubleshoot questionable results and equipment problems for timely resolution
Calibrate all lab equipment and keep records to appropriate Quality Standards