Quality and Compliance Project Manager at Nephron Pharmaceuticals in West Columbia, South Carolina

Job Description:

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.

Job Purpose:

Quality and Compliance Project Managers primary job purpose is to lead and execute projects that support the quality, compliance and operations, by developing and implementing processes, monitoring activities, and mitigating risks to maintain operational integrity and prevent regulatory issues. They have a role in maintaining the documentation to support the project and tracking in a way that can be evaluated as needed.

Essential Duties and Responsibilities:

• Expected to develop and execute integrated strategies that help realize the organization's purpose and drives responsible growth.
• Partner with functional leads to develop integrated plans aligned with the Quality System and promotes cGMP compliance.

· Support the Quality Unit to ensure that processes comply with internal procedures and regulatory requirements.

· Create and assist with projects to continuously improve the Quality System.

· Identifies resources needed and assigns individual responsibilities for various projects.

· Follow procedures to ensure change control of documents, equipment/process, materials, investigations, CAPAs, and audits are initiated, recorded, and implemented.

• Provide assistance and support for an effective Quality Unit.

· Participate and conduct inspection readiness activities, serving as a Quality representative during inspections.

· Present progress reports or presentations at appropriate intervals to multiple levels in the organization to support remediation monitoring to identify process gaps, validate compliance levels, and map processes.

· Ensures project documents are complete and current, with all documentation performed as necessary.

• Maintain strict company confidentiality.
• Team player with the highest of personal values and ethical standards.
• Ensures cross-functional alignment and accountability.
• Salary range: Based on experience
• Hours of work: 30-40 hours per week or as needed based on company demand.
• This position allows for remote work flexibility as determined by business needs.

Supplemental Functions:

• Performs other similar duties as required.

Job Specifications and Qualifications:

• Project Management Certification preferred

Knowledge & Skills:

• Excellent written and oral communication skills.
• Team player and must be able to interact with all departments.
• Ability to work independently and be dependable.
• Ability to manage, train, motivate, and discipline employees.
• Technical writing skills required.
• Strong attention to detail.
• Incumbents are required to wear specified protective equipment as necessary.
• The ability to identify work elements in detail, and develop work standards, and work method improvements; develop procedures, and forms to effect method improvement and work simplification.
• Specific expertise, skills, and knowledge of project management gained through education and experience.
• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to manage a multitude of resources and to be accurate and current with data and information.

Education/Experience:

• Bachelor of Arts or Science degree with 5+ years of pharmaceutical industry experience preferred.
• 2-5 years of experience with MS Word, Excel, and PowerPoint preferred.
• 2-4 years project management and coordination experience.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.

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.

Requirements:

Equal employment opportunity, including veterans and individuals with disabilities.

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