Quality Control and Continuous Improvement Specialist I

Inotiv; Denver (Lancaster County); On-site; USD 50,000 - 61,000; Full time

Job summary

Inotiv in Denver, PA is seeking a Quality Control professional to perform analyses, testing, and data interpretation across materials and processes, with travel to the Frederick, MD site. The role emphasizes CAPAs, regulatory compliance, and continuous improvement to support QA and manufacturing operations.

The position requires a 2+ year background in quality control or related roles, a Life Sciences/Engineering degree, and strong analytical, problem-solving, and communication skills.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 2+ years of experience in quality control or related operational role.
• Experience with NC/RCI/CAPA processes, audits, and regulatory compliance.
• Experience with Lean, Six Sigma, 5S, FMEA, process mapping, and statistical data analysis.
• Strong analytical, problem-solving, and communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional environment.

Responsibilities

• Perform scientific analyses of raw materials, in-process materials, and finished products to ensure quality.
• Test products according to QC protocols and specifications.
• Document and analyze QC data to identify trends and improvement opportunities.
• Lead root-cause investigations and CAPA implementation.
• Apply Lean, 5S, Six Sigma and process mapping to improve workflows.
• Collaborate with QA, Operations, and facilities to resolve production issues.
• Maintain QC records, SOPs, and ensure regulatory audit readiness.
• Mentor junior QC staff and promote a culture of continuous improvement.
• On-site full-time presence and willingness to perform additional duties.

Skills

Quality Control

Continuous Improvement

Lean

Six Sigma

5S

Process Mapping

Statistical Analysis

Problem Solving

Communication

Cross-functional

Education

Bachelor’s degree

Job description

This role is based out of Denver, PA with travel to Frederick, MD site. Base pay is 55,000 per year, but will commensurate with experience based on candidate's credentials.

Key Responsibilities

Quality Control & Product Testing

• Perform scientific analyses of raw materials, in-process materials, and finished products to ensure compliance with established quality standards.
• Select and test products according to defined QC protocols and specifications.
• Document, interpret, and analyze QC data to identify trends, deviations, and opportunities for process improvement.

Problem Solving & Process Improvement

• Take proactive ownership of problem identification, resolution, and risk mitigation.
• Conduct root cause investigations and assist in designing and implementing corrective and preventive actions (CAPAs).
• Use Lean, 5S, Six Sigma, process mapping, and other continuous improvement tools to optimize workflows, prevent defects, and improve efficiency.
• Develop and implement novel systems or tools to enhance quality and process reliability.

Operational Support & Collaboration

• Work collaboratively with QA, Operations, Veterinarians, Facilities & Maintenance, and other stakeholders to troubleshoot and resolve production or process issues.
• Participate in process development, optimization, and implementation across animal, feed, enrichment, laboratory, and operational functions.
• Support other operational functions as trained and qualified.

Documentation & Compliance

• Maintain accurate QC records, SOPs, work instructions, quality records, and other documentation in alignment with regulatory and internal standards.
• Ensure data integrity, audit readiness, and adherence to AAALAC, IACUC, USDA, CDC, and other relevant regulatory requirements.
• Provide on-site support for internal, customer, and regulatory audits.

Continuous Improvement & Team Support

• Participate in continuous improvement initiatives, including 5S activities, FMEAs, Gemba walks, and other operational excellence programs.
• Help drive a culture of continuous improvement and operational excellence by leading by example.
• Provide guidance, mentoring, and training to junior QC staff, supporting their professional development.

On-Site Presence & Additional Duties

• Full-time on-site presence is required.
• Perform additional duties as assigned to support QC and CI objectives.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 2+ years of experience in quality control, continuous improvement, or related operational role; laboratory or production environment experience preferred.
• Knowledge of NC/RCI/CAPA processes, audits, and regulatory compliance.
• Experience with Lean, Six Sigma, 5S, FMEA, process mapping, and statistical data analysis preferred.
• Strong analytical, problem-solving, and communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional environment.

Key Competencies

• Proactive, detail-oriented, and process-driven.
• Strong problem-solving and investigative capabilities.
• Effective collaboration and communication across cross-functional teams.
• Commitment to quality, continuous improvement, and regulatory compliance.
• This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.

At Inotiv, our work helps advance the development of new medicines and therapies that can improve people's lives. As a leading global contract research organization (CRO), we partner with researchers to tackle complex scientific challenges, drive innovation, and help build a healthier, safer world. Bringing together scientists, researchers, technical experts, and business professionals, we provide the expertise and collaboration needed to move research forward. Our people make this work possible, and we value the knowledge, ideas, and contributions each person brings to the team. Whether you are starting your career or bringing years of experience, Inotiv offers opportunities to learn, grow, and play a meaningful role in advancing treatments for patients around the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.