Technician Analytical Lab

VIVOS HOLDINGS•Mooresville, IN

About The Position

The Analytical Technician is responsible for accurate analysis of various chemical testing within the QC laboratories to ensure quality production of Nice-Pak products through use of Good Laboratory Practices and accurate documentation. REPORTING & ANALYSIS: Perform required analytical and chemical testing according to NPTMs, SOPs and WIs on raw materials, bulk liquids and finished products. Perform non-routine chemical testing such as flush samples, sanitizer verifications and investigations. Ensure that all results are accurately recorded in appropriate laboratory notebooks and another designated forms according to GLP’s. Provide production and other plant areas technical expertise and analytical skills to facilitate problem solving and root cause analysis. Order laboratory analytical supplies and monitor inventory levels. Prepare standards and perform equipment calibrations and verifications. Prepare / revise laboratory procedures (WIs, methods, SOPs, etc.) when required. Review lab notebooks for 21CFR section 11 compliance. All other duties as assigned. The above is intended to describe the general content of and requirements for the performance of this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements. TECHNICAL EXPERTISE: Develop and perform validation studies when required. Ensure compatibility between process capability and Finished Product Specifications. Recommend equipment purchases and upgrades. Support and perform method transfers and validations. Present lab results in monthly meetings. Prepare / revise laboratory procedures (WIs, methods, SOPs, etc.) when required Leadership: Handle special projects and assign them when required. Furnish reports, as necessary, to the QA/QC manager, quality director, or designee. Quality Planning and Continuous Improvement: Quality team problem solving and root cause analysis. Assist with site cost savings goals as they relate to Quality. Develop and implement short- and long-range goals and plans for continuous improvement.

Requirements

Bachelor’s degree in chemistry or other related science degree.
Analytical methods and theories. Able to incorporate them into daily talks and problem solving.
Able to follow test methodology accurately and precisely.
Knowledge of computer software such as Microsoft Excel, Word, Access, LIMS, etc.
At least one year experience as a technician in an Analytical laboratory environment, preferably in a manufacturing environment regulated by 21 CFR 210-211.
Strong analytical skills with the ability to conduct root cause analysis for out of specification results.
Good verbal and written communication skills demonstrated by the ability to generate technical reports.
Ability to learn new test methods and minimize documentation errors in a cGMP environment.

Responsibilities

Perform required analytical and chemical testing according to NPTMs, SOPs and WIs on raw materials, bulk liquids and finished products.
Perform non-routine chemical testing such as flush samples, sanitizer verifications and investigations.
Ensure that all results are accurately recorded in appropriate laboratory notebooks and another designated forms according to GLP’s.
Provide production and other plant areas technical expertise and analytical skills to facilitate problem solving and root cause analysis.
Order laboratory analytical supplies and monitor inventory levels.
Prepare standards and perform equipment calibrations and verifications.
Prepare / revise laboratory procedures (WIs, methods, SOPs, etc.) when required.
Review lab notebooks for 21CFR section 11 compliance.
Develop and perform validation studies when required.
Ensure compatibility between process capability and Finished Product Specifications.
Recommend equipment purchases and upgrades.
Support and perform method transfers and validations.
Present lab results in monthly meetings.
Handle special projects and assign them when required.
Furnish reports, as necessary, to the QA/QC manager, quality director, or designee.
Quality team problem solving and root cause analysis.
Assist with site cost savings goals as they relate to Quality.
Develop and implement short- and long-range goals and plans for continuous improvement.