Director of Calibration - Military veterans preferred

Nephron Pharmaceuticals


Description:

Corporate Statement:

Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.

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Job Purpose:

The Director of Calibrations is responsible for overseeing the calibration program for all critical instruments, equipment, and systems within the pharmaceutical manufacturing facility. This leader ensures compliance with cGMP, FDA, and other applicable regulatory requirements while driving continuous improvement, risk mitigation, and operational excellence across calibration processes. The role collaborates cross-functionally with Quality Assurance, Maintenance, Engineering, Production, and Regulatory teams.

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Essential Duties and Responsibilities:

Ø Lead the design, implementation, and management of the site-wide calibration program for all GMP-critical instruments and equipment.

Ø Develop, implement, and maintain the site's calibration policies, procedures, and work instructions to ensure compliance with regulatory requirements, industry guidelines, and internal standards.

Ø Oversee a team of calibration professionals, including technicians, supervisors, and managers providing guidance, training, and performance management to ensure efficient and effective execution of calibration tasks.

Ø Manage external calibration service providers and vendor performance.

Ø Develop and track key performance indicators (KPIs) for calibration metrics such as schedule adherence, out-of-tolerance investigations, and overdue calibrations.

Ø Develop and maintain the site's calibration master plan and ensure adherence to the established schedules.

Ø Establish calibration procedures, methods, and acceptance criteria based on risk and criticality assessments.

Ø Ensure that all calibrated equipment is properly labeled, tracked, and maintained in a validated state.

Ø Partner with Quality Assurance to manage deviations, CAPAs, and change control related to calibration activities.

Ø Collaborate with Engineering and Validation departments on the qualification and validation of new equipment and systems, ensuring calibration requirements are integrated into the lifecycle.

Ø Participate in internal and external audits, providing expertise and ensuring the calibration program meets all regulatory and quality requirements.

Ø Develop and report key performance indicators (KPIs) related to the calibration program, identifying trends and implementing improvements as needed.

Ø Manage the calibration budget, ensuring efficient utilization of resources.

Ø Stay current with industry trends, regulatory changes, and technological advancements in calibration practices.

Ø Ensure proper documentation and record-keeping of all calibration activities, including calibration certificates, reports, and maintenance logs.

Ø Promote a culture of quality and continuous improvement within the calibration team and across the organization.

Ø Lead root cause analyses and corrective action efforts for OOT (Out of Tolerance) events.

Ø Optimize calibration frequencies using historical data and reliability-centered maintenance principles.

Supplemental Functions:

Ø Performs all other duties as assigned or apparent.

Job Specifications and Qualifications:

Education / Experience:

Ø Bachelor's degree in Engineering (Electrical, Mechanical, Instrumentation), Metrology, or a related scientific discipline. Master's degree preferred.

Ø Minimum of 10 years of experience in calibration within a pharmaceutical or other highly regulated pharmaceutical or biotech manufacturing environment, preferred.

Ø Minimum of 5 years of experience in a supervisory or management role, leading a team of technical professionals.

Ø Thorough understanding of cGMP, FDA, and ICH regulatory requirements and other relevant industry guidelines related to calibration.

Ø Strong technical knowledge of various calibration principles, techniques, and instrumentation (e.g., pressure, temperature, flow, weight, dimensional, electrical).

Ø Experience with Blow Fill Seal (BFS) manufacturing processes and equipment is highly desirable.

Ø Proficiency in using calibration management software and systems.

Ø Excellent problem-solving, analytical, and root cause analysis skills.

Ø Strong leadership, communication (written and verbal), and interpersonal skills.

Ø Experience with lean manufacturing and continuous improvement methodologies, ability to work independently and collaboratively in a cross-functional team environment.

Ø Experience in managing and interacting with external calibration vendors.

Ø Demonstrated ability to develop and implement effective calibration programs and procedures.

Ø Experience participating in and supporting regulatory audits.

Licensing and Certifications:

Ø Professional certifications in calibration (e.g., ASQ Certified Calibration Technician - CCT).

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Working Conditions / Physical Requirements:

Ø Position requires bending (desk to floor), lifting (up to 40 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.

Ø Salary range: Based on experience.

Ø Hours of Work: Compensation is based on 40 hours per week. Additional hours may be necessary based on the business need. Generally speaking, Monday – Friday 8:00 am to 5:00 pm.

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The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description.

Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

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