Quality Technical Services Scientist (Level 1)

Job Purpose Statements

The Quality Technical Services Scientist (Level 1) focus areas are for USP Purified Water (USP PWS), Environmental Monitoring (EM), Cleaning Validation or Verifications (CV) and Area Temperature and Humidity data and controls. The QTSS creates and as needed can execute Cleaning Validation (CV) protocols, campaigning, and assessments to the Cleaning Matrix. The QTSS uses their knowledge of equipment, processes, and personnel practices to review and provide feedback for corrective actions or instructional improvements to their focus area projects and processes. The QTSS collects and analyzes workday temperature, humidity as well as analytical testing or microbiological or other such laboratory data for respective Mapping or for QC database uses. The data is used for tracking and trending, for timely reporting, addressing alarms and including arranging for non-routine servicing.

The QTSS position reviews laboratory test data pertaining to USP PWS, EM, and CV including microbiological data results providing technical assistance to system owners based on trends. Quarterly Reports, Conditional Release, and Final Release Reports are created with concluding status statements. The QTSS coordinates non-routine sampling and testing activities with Quality Technicians.

Main Accountabilities

• Create and execute Environmental Monitoring (EM), USP PWS, CVs, Campaign Documents, and routine Area Temperature Mapping and reporting.
• Applies critical thinking for assessments of project, area or product risks and developing timely corrective action plans based upon analyzed data.
• Create and maintain data for internal management reporting and trending purposes for Environmental Monitoring, USP Purified Water Systems and Area Mapping.
• Multi-tasking and interdepartmental communication skills to ensure (temperature/humidity/microbial etc.) compliance for their focus areas and systems.
• Development and completion of Change Control Action Items as needed with system owner and Project Planner for QTSS focus areas.
• Gain technical knowledge for establishing basic preventative maintenance, system, and calibration requirements for area focus systems. (Example: Learn and master Vaisala ViewLinc and related equipment systems and databases and how to use them for Temperature Mapping and Data Monitoring purposes.)
• Identify and justify where possible, Technical improvements to systems and programs to drive greater efficiencies and compliances. (Continuous Improvements)
• Continue to learn and develop for Validation and Qualification related documentation and system requirements for areas of focus. Understand document creation process for test execution principles and especially those for equipment or system changes related to the focus areas.

Job Related Qualification/Skills

• Bachelor’s degree preferably in scientific or engineering disciplines or bachelor’s degree and applicable work experience.
• Excels in compiling multiple forms of documents and forms of communications. Able to describe, simplify, organize , write, and document testing in cGDP format. Ensure system control and compliance.
• Progressive experience within a cGMP environment with working knowledge of CFR 210, 211, 820 and 21 CFR Part 11 is preferred.
• Ability to understand microbiological reports with an understanding of microorganisms of concern.
• Ability to problem solve and engage in diverse cross functional teams to achieve business objectives.
• Excellent written and verbal communications skills.
• Understanding of foundational cGXP principles and the pillars of quality systems and can assure projects and equipment are within those quality systems.
• Service-centered, team building, positive respectful professional attitude toward work and personnel.
• Ability to write, improve and provide technical assistance supporting Standard Operating Procedures for focus areas.
• Ability to handle multiple tasks simultaneously, having good planning and organizational skills.
• Strong proficiency in Microsoft Office suite of products.
• Experience with equipment or instrument application software and equipment control systems hardware/software/firmware with the ability to navigate and document varied human-machine interfaces. (Desired)

NOTE: This job profile is intended to provide an overview of expected job duties and requirements. It is not intended to be a contract of employment, explicit or implicit. All contents are subject to change at the sole discretion of the company. Cooperation is expected of all employees. Other duties may be assigned as needed.

We offer a competitive benefits package including, health, dental, paid time off, vision, short/long term disability and 401(k) w/match.

Equal Opportunity Employer

Learn more about the Crown family of products:

Crown Therapeutics: maker of PanOxyl®, the #1 acne wash; Blue Lizard® Australian Sunscreen, the #1 Pediatrician recommended mineral-based sunscreen brand; and Sarna®, the #1 Dermatologist recommended topical anti-itch brand and National Seal of Acceptance from the NEA, and more.

Crown Premium Skincare: includes StriVectin, comprised of a broad range of award-winning skincare solutions for all skin types, tones, and ages; and Vita Liberata, a multiple award-winning sunless tanning brand.

Crown Laboratories does not accept unsolicited resumes from individual recruiters or third-party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Crown Laboratories vendors who have been expressly requested to make a submission by our HR team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Crown Laboratories HR team and such candidate was submitted to the Crown Laboratories HR team.

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