QC Chemist

Vantage•Englewood, OH

16h•$26 - $30

About The Position

POSITION SCOPE The creation of methods as needed, verification and validation of pre-existing methods to establish as a Standard Operating Procedure for the testing of raw materials and finished good products. Maintain equipment and laboratory compliance for all equipment used. Ensure solutions and standards are made and available, and up to date. Ensure laboratory is clean and safe for the handling of chemicals. Carry out QC lab analysis of raw materials, in process samples and final products so that results are accurately determined, carried out in a timely way, properly communicated to customers, and carried out within the framework of the Quality System ISO 9000 and FSSC 22000/22002 with cGMP applying. This ensures that the manufacturing operation is well supported, and outside customers promptly served with the correct product, quality and information. ESSENTIAL DUTIES AND RESPONSIBILITIES Key responsibilities include, but are not limited to the following: Carry out QC analytical work and the requirements exactly to the required written methods and using the correct equipment, so that information to internal and external customers is accurate, timely and properly reported and in compliance as applicable per product type. (food, drug) Carry out all work to the appropriate Quality Standards - ISO 9000 as well as FSSC 22000/22002 also applying cGMP food safety/ drug safety related to designated area. Knowledge and access to USP monograph for drug testing. Immediately report any accidents or hazardous incidents including any issues with food/drug safety, food/drug raw materials, finished goods or any concerns whatsoever regarding food and drug products as required by the FDA and GFSI standards to management immediately. Comply, maintain, train, and enforce contractors to ensure all third parties have been qualified to meet all cGMP, GFSI, ISO, food safety requirements as applicable for the overall site. Communicate fully with internal and external customers so that their requirements and results are fully understood and any interpretation of the information is properly supplied. Work independently, as well as in a team, so that work is smoothly and efficiently handled, shift hand-over is completed with a full understanding of ongoing issues, production operators are supported in their in-process testing and the lab manager/supervisor is kept appraised of issues and how they are being handled. Spot and troubleshoot questionable results and equipment problems so that resolution of the matter is obtained in a timely manner, and the proper people kept informed or asked for guidance. Calibrate all lab equipment and keep records to the appropriate Quality Standards so that the equipment is always ready for use. Suggest and run small projects, within the general scope of work done in the QC Lab, so that the lab improvements can be made. Follow all Company policies, procedures, and instructions using cGMP so that work is properly and safely done, the quality system maintained, and good housekeeping is carried out. Internal audit certification is required to audit to ISO 9001:2015 and FSSC 22000:2018, GMP ICHQ7 Standards. The ability to conduct investigations on out of specification results, customer complaints and assist the QC team with investigation, root cause analysis and Corrective and Preventive Actions. The ability to review documentation to ensure there are no unapproved deviations, and for accuracy using Good Documentation Practices. Physically inspecting equipment, conducting swabs for approval to use in clean room environments. Note: The duties listed above are not all inclusive and may be subject to periodic updating or revision.

Requirements

A minimum of an associate’s degree in physical science and a minimum of 3 years of laboratory experience.
Must be able to apply good safety practice, good laboratory practice (GLP) - cGMP, and operate to the quality regime, i.e. ISO 9000 as well as FSSC 22000/22002 and have a basic understanding of cGMP requirements, CFR requirements for the sampling and testing of USP pharmaceutical products.
Must be fully conversant with all the instrumental analysis and wet chemistry in the QC Lab and in particular the following techniques: HPLC, automated titrations, physical property testing, color measurement, and spectroscopic techniques; as well as be able to teach the techniques, demonstrate good lab practice, do basic troubleshooting, and maintain good records including lab books.
A good sense of smell is required for organoleptic testing.
Computer skills are required as the chemists must be able to use databases, spreadsheets, word processing software, LIMS and computer controlled instruments.
Must have good written and verbal communication skills.
Good organizational skills, decision-making and record keeping skills are also required.
The ability to work in a team environment as well as independently with minimal supervision is necessary.
Flexibility to work any other shifts and be able to work overtime as required.

Responsibilities

Carry out QC analytical work and the requirements exactly to the required written methods and using the correct equipment, so that information to internal and external customers is accurate, timely and properly reported and in compliance as applicable per product type. (food, drug)
Carry out all work to the appropriate Quality Standards - ISO 9000 as well as FSSC 22000/22002 also applying cGMP food safety/ drug safety related to designated area. Knowledge and access to USP monograph for drug testing.
Immediately report any accidents or hazardous incidents including any issues with food/drug safety, food/drug raw materials, finished goods or any concerns whatsoever regarding food and drug products as required by the FDA and GFSI standards to management immediately.
Comply, maintain, train, and enforce contractors to ensure all third parties have been qualified to meet all cGMP, GFSI, ISO, food safety requirements as applicable for the overall site.
Communicate fully with internal and external customers so that their requirements and results are fully understood and any interpretation of the information is properly supplied.
Work independently, as well as in a team, so that work is smoothly and efficiently handled, shift hand-over is completed with a full understanding of ongoing issues, production operators are supported in their in-process testing and the lab manager/supervisor is kept appraised of issues and how they are being handled.
Spot and troubleshoot questionable results and equipment problems so that resolution of the matter is obtained in a timely manner, and the proper people kept informed or asked for guidance.
Calibrate all lab equipment and keep records to the appropriate Quality Standards so that the equipment is always ready for use.
Suggest and run small projects, within the general scope of work done in the QC Lab, so that the lab improvements can be made.
Follow all Company policies, procedures, and instructions using cGMP so that work is properly and safely done, the quality system maintained, and good housekeeping is carried out.
Internal audit certification is required to audit to ISO 9001:2015 and FSSC 22000:2018, GMP ICHQ7 Standards.
The ability to conduct investigations on out of specification results, customer complaints and assist the QC team with investigation, root cause analysis and Corrective and Preventive Actions.
The ability to review documentation to ensure there are no unapproved deviations, and for accuracy using Good Documentation Practices.
Physically inspecting equipment, conducting swabs for approval to use in clean room environments.