Ventura Solutions

Laboratory Manager

Ventura Solutions  •  Chicago, IL (Onsite)  •  3 hours ago
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Job Description

Our client is seeking a Laboratory Manager to oversee the daily operations of a laboratory to ensure a safe, efficient, and compliant working environment. This role is responsible for supervising laboratory personnel, managing equipment and inventory, ensuring adherence to regulatory standards, and supporting projects by maintaining high operational quality.

Responsibilities

  • Maintain data integrity and ensure compliance with company procedures and specifications, FDA, cGxP, and QSR regulations.
  • Perform reviews of test data, including overall documentation practices.
  • Ensure that laboratory equipment is calibrated and maintained.
  • Select and order new equipment and tools as necessary.
  • Perform testing in a timely and appropriate manner to meet project schedules.
  • Enforce the application of laboratory rules and procedures.
  • Lead and organize all activities of the laboratory, including planning, organization of work, and reporting.
  • Deploy environment, health, and safety policies to prevent accidents, safeguard the environment, and better control consumption and waste.
  • Deploy applicable quality policies and procedures within the laboratory to ensure compliance with applicable regulatory requirements.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data; may be required to serve as a system owner and conduct validations.
  • Ensure adequacy between necessary skills and company objectives, including participating in the definition of recruitment needs, assessing employee performance, drawing up training plans, and managing the integration and training of new hires.

Qualifications

  • Bachelor's or Master's degree in Engineering, Science, or a related field.
  • 7–10+ years of experience working in a laboratory environment for regulated industries such as pharmaceutical or medical device.
  • 3+ years of lab operations and personnel management experience required.
  • Experience with quality tools such as Measurement System Analysis, Gage R&R, and Design of Experiments.
  • Experience with mechanical testing.
  • Strong leadership and communication skills.
  • Excellent organizational and time-management abilities.
  • Knowledge of lab safety regulations and compliance requirements.
  • Ability to troubleshoot equipment and process issues.
  • Detail-oriented with strong documentation practices.
  • Experience with laboratory information management systems is a plus.

Location

  • Chicago, IL

Employee Type

  • Direct Hire

Compensation & Benefits

  • Salary range: $110,000–$130,000 USD
  • Health insurance
  • Paid time off and holidays
  • 401(k)

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Ventura Solutions

About Ventura Solutions

Ventura Solutions provides End-to-End consulting, staffing, and training services for the Medical Device and Combination Products industry.

We provide consulting, staffing, and training solutions in the following areas:

-Design Controls

-Risk Management

-Verification & Validation

-Design and Development

-Project Management

-Quality

-Regulatory

-Human Factors

-DHF & Quality System Remediation

-Software as a Medical Device (SaMD)

-Statistics

-Clinical Affairs

-Market Access

-Funding

-NIH SBIR Grants

-Start-Ups

Ventura Solutions is your one-stop shop for getting your product to the market or keeping it compliant.

Detailed list of areas of expertise:

Medical Device & Combination Product Consulting

Design Controls, Risk Management, 21 CFR 820.30, ISO 13485, ISO 14971, Design and Development, Systems Engineering, Project Management, Quality Assurance, Human Factors, IEC 62366, Usability, Design Verification, Design Validation, Statistics, Design History File (DHF) Remediation, Software as a Medical Device (SaMD), Manufacturing, Change Control, Regulatory, FDA Q-Sub, Pre-Sub, Breakthrough Device Program (BDP), Investigational Device Exemption (IDE), 510(k), MDR

Medical Device Start-Up & Business Consulting

Co-Development Deals, Licensing Deals, Fundraising, Non-Dilutive Funding, NIH SBIR Funding, Mergers and Acquisitions (M&A), Commercialization, Valuations, Equity Distributions, Board of Directors, Leadership, Organizational Development, Building High Performing Teams, Concept Evaluation & Selection, FDA or EU Regulatory Strategy, Value Proposition

Staffing, Direct Placement, & Executive Recruitment

Medical Device Engineers, Risk Management Engineers, Systems Engineers, Human Factors Engineers, Design Verification & Validation Engineers; Test Method Development Engineers, Materials Engineers, Project Managers; Process Validation Engineers, Process Development Engineers, Quality Engineers, Design Assurance Engineers, Regulatory Affairs Specialists

Industry
Manufacturing & Production
Company Size
11-50 employees
Headquarters
Vernon Hills, IL
Year Founded
2016
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