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Quality Control Analytical Scientist

Company: Yoh, A Day & Zimmermann Company
Location: Lewisville
Posted on: January 11, 2022

Job Description:

Scientist - Quality Control Analytics

Contract to Hire

Lewisville, TX (Onsite)

M-F 11AM-7:30PM with rotation of the weekends every six weeks.

Looking for a candidate with previous analytical & stability experience. Preferably 5-7 years of industry experience whether Pharma, Medical devices or Cosmetics, if possible. Analytical raw materials or bulk

Laboratory equipment and stability related.

Bachelor's degree in Chemistry.

5+ years of laboratory environment experience or equivalent. Prior work experience in a quality control laboratory is preferred. 5 years is ideal raw materials as well as bulks

Must have a good understanding of Chemistry and laboratory instrumentation


Provide a high-level summary of the overall purpose, scope and objective(s) of the job that explains why the job exists.

Analyzes both chemical and physical testing of raw materials, bulk, finished goods and stability, provides quality disposition of the analysis, coordinates out of specification investigation, implements corrective actions for investigations, method transfer, suggests and implements continuous improvements. Works with the lab team to achieve efficient functioning of the quality control analytical laboratory. Understands FDA and current Good Manufacturing Practices. Responsible for stability protocol initiation and approval, pull schedule adherence, OOS investigation and resolution

Under general guidance, independently performs analytical tests utilizing chromatography, spectroscopy, wet chemical analysis, and other known tests according to Good Laboratory Practices (GLP) on raw materials, bulk, finished goods and stability manufactured for release to the market. Assists Processing with batch color corrections, if needed.

Documents test results and makes decision for product acceptance and rejection based on the results to the product specification and releases the product within the Laboratory Information Management System, LIMS. Facilitate stability pull intervals and coordinate sampling. Initiate stability studies in MKBS and ensure result recording according to applicable specification.

Manages the daily lab priorities alongside other scientists by assisting them in good laboratory techniques, practices, and procedures. Documents receipt of samples and records data on laboratory datasheet and on computer system. Prepares worksheets and paperwork related to release various types of samples and coordinate external testing in conformance with approved study. Prepares records necessary to track "hold" items. Conduct Out of Specification investigations on raw materials, bulk, finished goods and stability samples.

Manages raw material program and OTC Annual Product Review by analyzing the data and recommending changes as needed to leadership.

Responsible for the IQOQPQ, calibration, and maintenance of laboratory equipment to ensure compliance with FDA regulations.

Interfaces with other cross functional teams within Quality, Product Integrity, Purchasing, Planning, Receiving, Central Weigh, Marketing, PE, Product Commercialization, Product Development, Document Control, Quality Technical Services, Quality Systems, Quality Assurance, Microbiology, Process Development, and Manufacturing to obtain samples, discuss test results, gather information, increase understanding of quality testing, and make recommendations as appropriate.

Leads lab investigations for out of specification results and implements corrective and preventative actions. Facilitate collaboration between cross-functional departments to resolve Out of Specification investigations.

Coordinates, trains, and executes method transfer with R&D.

Suggests and implements continuous improvement projects and best practices to improve the overall working environment of the lab. Execute tasks as assigned to improve laboratory efficiency.

In addition to the above, incumbent is expected to meet the required competencies for this position as defined in the competency profile.


Bachelor's degree in Chemistry.

3+ years laboratory environment experience or equivalent. Prior work experience in a quality control laboratory is preferred.

Must possess both oral and written communication skills in order to make and present recommendations and information and effectively interact with scientific and non-scientific personnel to convey a scientific perspective.

Must have a good understanding of Chemistry and laboratory instrumentation to make sound decisions based on the technical information available.

Must have a thorough understanding of FDA regulations and current Good Manufacturing Practices.

Must understand the relationship between the values and goals of the organization to the quality control function.

Must have "average discrimination" based on the Farnsworth-Munsell Hue Test in order to visually distinguish colors; must also be able to distinguish fragrances.

Must possess the manual dexterity required to perform tests on materials and manipulate instruments.




Keywords: Yoh, A Day & Zimmermann Company, Lewisville , Quality Control Analytical Scientist, Other , Lewisville, Texas

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