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Associate Director, Quality Control; Microbiology

Job in High Point, Guilford County, North Carolina, 27264, USA
Listing for: Merck & Co.
Full Time position
Listed on 2026-06-21
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 100000 - 125000 USD Yearly USD 100000.00 125000.00 YEAR
Job Description & How to Apply Below
Position: Associate Director, Quality Control (Microbiology)

Position Overview

The Associate Director, Quality Control (Microbiology) is responsible for leading the QC Microbiology team to ensure on‑time analysis of manufactured product and environmental monitoring samples. The role guarantees all testing complies with applicable regulations, company specifications, procedures, and policies at Fujifilm Diosynth Biotechnologies.

Responsibilities
  • Create a safe working environment within QC through a culture of behavioral safety and adherence to site EHS policies.
  • Ensure the team is actively engaged in the on‑time delivery of routine operations and annual objectives.
  • Maintain the QC Laboratories in a state of audit readiness, present on QC topics, and lead tours for client and regulatory inspections.
  • Manage the team for excellence in laboratory investigations and on‑time completion of CAPA and Change Control.
  • Ensure appropriate team training requirements are established and compliance is maintained with assigned curricula.
  • Oversee microbial and environmental control in the manufacturing facility.
  • Champion continuous improvement by providing resources and developing the team to evaluate and improve current processes.
  • Invest in development and actively manage performance of individuals.
  • Adhere to QC expense and capital budget.
  • Supervise 10 or more exempt or non‑exempt staff.
  • Contribute to the development of the capital and expense budget and have approval authority as defined in the company’s authorization matrix.
  • Manage departmental activities to meet or exceed company objectives regarding revenue, profit plan, supply, and compliance.
Minimum Requirements
  • Bachelor of Science in Microbiology or related technical field and 12+ years of experience.
  • Knowledge and experience of Bioburden, endotoxin, and EM testing.
Preferred Qualifications
  • Master’s of Science with 10+ years OR PhD with 8+ years of experience in a GMP laboratory environment.
  • 5 years of supervisory experience.
  • Experience working in a lean manufacturing or Six Sigma environment.
  • Experience with LIMS and other data management systems.
Specific Skills and Competencies
  • Demonstrated leadership, technical aptitude, and problem‑solving skills.
  • Adaptable and able to manage and prioritize multiple tasks and assignments.
  • Excellent verbal and written communication skills and ability to articulate issues with peers and colleagues at all levels.
  • Capability in a cross‑functional team environment, working cooperatively to attain goals while encouraging teamwork and synergies.
  • Proficient technical writing skills.
  • Able to make informed and timely decisions independently.
  • Capable of recognizing process gaps and implementing improvements.
  • Demonstrated leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization.
  • Strong team skills, including coaching/developing work teams, providing training, motivating/empowering others, and resolving conflicts.
  • Goal‑oriented and able to manage risks.
Working Conditions &

Physical Requirements
  • Ability to stand for prolonged periods of time.
  • Ability to sit for prolonged periods of time.
  • Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
  • Ability to conduct work that includes moving objects up to 10 pounds.
Benefits

Our programs focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision, and prescription drug coverage, a Health Savings Account with company contributions, an industry‑leading 401(k) savings plan, insurance coverage, employee assistance programs, and various wellness incentives. We support work‑life balance with paid vacation time, sick time, and company holidays, and provide opportunities for personal and professional growth.

EEO

and ADA Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation, gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, or any other protected characteristic. If you require reasonable accommodation in completing this application, interviewing, or any pre‑employment testing, please contact our HR Department at

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Position Requirements
10+ Years work experience
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