Company:

Essential

• Perform quality control tests in the lab as well as on-site when necessary.

• Assist with testing and calibrating lab equipment in preparation for specific tasks.

• Perform quality control tests on ingredients, completed products and product samples.

• Prepare samples prior to shipping them to customers.

• Follow all company policies and procedures to ensure product integrity and quality control.

• Analyze retrieved data and prepare reports for laboratory management.

• Perform risk assessment investigations as needed based on trending data.

• Data Review & Analytics: Perform statistical review and trend analysis on manufacturing, testing, and process data to proactively identify process variability, operational gaps, and potential quality risks.

• Non-Conformance & Root Cause Investigations: Lead cross-functional root cause analyses (using methodologies such as 5-Why, Fishbone, FMEA) for bulk, raw material, and out-of-specification (OOS)/out-of-trend (OOT) investigations; evaluate and document technical rationales.

• Validation Program Management: Plan, execute, and document cleaning validation, process validation, and equipment qualification protocols (IQ/OQ/PQ) to ensure operational compliance and sanitary control.

• Environmental Monitoring (EM) Oversight: Provide engineering and technical oversight for the site Environmental Monitoring program, evaluating environmental controls, airflow/cleanroom integrity, and utility systems (e.g., purified water systems).

• CAPA Execution & Effectiveness Verification: Design targeted CAPAs to address identified process gaps and design verification protocols to measure the long-term effectiveness of implementation.

• Process Risk Assessments: Conduct formal quality risk assessments (QRA) on operational changes, new raw material implementations, and process modifications to maintain product safety and compliance.

• Quality Systems Support: Draft, revise, and review technical SOPs, validation protocols, control charts, and technical reports for site leadership and regulatory audits.

Qualifications/Knowledge, Skills, & Abilities Requirements

• Education: Bachelor’s degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, Bioengineering, or a related technical STEM discipline.

• 2+ years’ laboratory experience in food manufacturing environment. experience in quality assurance, Good Lab Practices, and current Good Manufacturing Practice. (Preferred)

• Experience: 2–5 years of progressive Quality Engineering or Quality Control experience within an FDA-regulated manufacturing environment (Cosmetics, OTC, Pharmaceuticals, or Medical Devices).

• Technical Skills:

  • Proven experience with root cause analysis (RCA) tools, CAPA systems, and statistical process control (SPC).

  • Direct experience developing and executing Cleaning Validation protocols and managing Environmental Monitoring programs.

  • Strong working knowledge of cGMP, ISO standards (e.g., ISO 22716 / ISO 13485), and GLP guidelines.

• Capable of prioritizing tasks to meet goals and ensure product quality.

• Willing to meet on-call obligations as needed.

• Ability to communicate effectively.

Machines Typically Operated

·Computer operations, word processing, spreadsheet, comprehensive statistical package, etc., pH meter, Scale, Analytical Scale, Hardy Diagnostics Compact Dry Micro Plating, Instrument Calibration, and Soleris microbiology system.

·Enterprise software systems (QMS, LIMS, ERP, Data Historians).

·Statistical analysis packages (Minitab, JMP, Advanced Excel).

·Analytical laboratory and process monitoring equipment (pH meters, analytical balances, water sampling tools, air samplers, calibration standards).

Typical Physical Requirements

·Work Intensity: Light work—exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to transport testing equipment or process samples.

·Activities: Balancing, reaching, standing, walking, feeling, talking, hearing, and repetitive motions required during cleanroom walkthroughs, floor audits, and validation execution.

·Visual Acuity: High visual acuity required for analyzing statistical datasets, reading technical schematics (P&IDs), inspecting fine component defects, and operating measurement instrumentation.
 

Typical Environmental Conditions

·Split between a standard administrative/office environment (data analysis, report drafting) and active manufacturing/laboratory spaces (cleanrooms, compounding rooms, and utility areas).

·Personal Protective Equipment (PPE) may be required depending on operational areas (e.g., cleanroom gowns, safety glasses, lab coats).

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle, or feel objects, tools or controls. The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position.  Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities.  To perform this job successfully, the incumbents will possess the skills aptitudes and abilities to perform each duty proficiently.  Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others.  The requirements listed in this document are the minimum levels of knowledge, skills or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

Our Benefits & Perks:

You will be part of an engaged, inclusive, global community that values family, giving back, beauty, and sustainability. We offer competitive benefits to eligible employees with comprehensive medical, vision, and dental coverage; supplemental life, voluntary short-term, and disability insurance; free access to therapists; a health savings account and 401k. You'll also be empowered to prioritize what's important to you through our vacation policy.