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Quality Manager Drug & OTC Manufacturing

Charlotte's Web
Louisville, CO Full Time
POSTED ON 2/14/2025
AVAILABLE BEFORE 5/11/2025

The Drug & OTC Manufacturing Quality Manager provides support for Internal and External Audits, Certification renewal and for ensuring a state of audit readiness by understanding, implementing and enforcing regulatory requirements. The Drug & OTC Quality Manager ensures that all company products meet quality, regulatory and safety standards before they go to market.

Essential Duties and Responsibilities :

  • Performs professional Quality Engineering assignments of considerable complexity under limited direction supervision i.e. Conducts statistical analysis in the form of capability studies, DOE’s, etc. to evaluate processes.
  • Designs, installs and continually evaluates quality assurance and / or control methods and systems.
  • Develops standards, procedures, and work instructions to provide quality guidance and to facilitate training activities.
  • Performs training in internal auditing, mechanical inspection and statistical techniques.
  • Develops sampling plans and statistical methods to be utilized by manufacturing and inspection in assessing the quality levels of products and processes to include determination of control points and charting methods.
  • Interfaces with engineering, to design fixtures and processes to ensure the effectiveness of measurement systems.
  • Conducts internal and external audits and supplier surveys to verify capability and / or compliance.
  • Coordinates and participates in material review activities to determine nonconforming product dispositions and corrective actions.
  • Develops, generates, and analyzes reports and returned products to identify trends and to facilitate corrective action / quality improvements.
  • Provides technical guidance to all personnel to assist in the use of statistical process control and problem-solving techniques.
  • Plans, conducts and takes action regarding gauge R&R, product and process capability studies.
  • Performs QE liaison activities as required to support internal / external customer service and satisfaction
  • Perform other duties as directed

Job Requirements :

Work Experience : 6 years of experience in pharmaceutical manufacturing.

Education : Bachelors Degree in Science (Chemistry, Biology, Engineering, Math) or equivalent experience required.

Skills :

  • Demonstrated knowledge of cGMP Regulatory Requirements
  • Demonstrates excellent organizational and communication skills and proficiency with the MS Office Suite, and statistical software
  • Must be able to work independently with minimal supervision
  • Able to prioritize projects and manage resources to meet organizational goals and objectives
  • Physical Demands and Work Environment :

    While performing the duties of this job, the employee is frequently required to pick up and lift up objects, sit, stand, walk, bend, squat, and twist. The employee must be able to lift and / or move up to 40 pounds.

    Benefits :

    Charlotte's Web offers a diverse, quality work environment, a great compensation package, and a comprehensive benefits package. Our benefits include medical / dental / vision insurance, pet insurance, 401K match, short and long-term disability, flexible PTO, and sick time. We are an Equal Opportunity Employer.

    Employees may be eligible for a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results.

    Recruiting for this role ends on ­­­­­­­­2 / 28 / 2025

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