Quality Control Microbiology Project Coordinator

Corporate Statement

Nephron Pharmaceuticals Corporation 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, ophthalmics, 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. Nephron is currently working on research and development projects that include over 50 new products. 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 Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone.

Position Summary:

• Creates and executes Quality Control Microbiology project work plans and revises, as appropriate, to meet changing needs and requirements of the department.
• Assists in the daily management of operational aspects of Product Development Studies, Equipment Validations, JOS, testing procedures, SOPs, and other documents, as needed, and reports project status to upper management.
• Ensures operational efficiencies and works on continuous improvement efforts.

Primary Accountabilities:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager

· Coordinates and completes the review of Microbiology documents in the laboratory including logbooks, laboratory notebooks, hood cleaning binders, and others as assigned.

· Coordinates resources to complete final QC Microbiology management review for samples in LabVantage and/or paperwork.

· Establishes a timeline for each phase of projects, as well as a completion date for the entire project. Also provides the QC Microbiology background and input for interdepartmental projects.

· Identifies discrepancies and initiates updates to procedures (TrackWise Digital); assists in coordination of Equipment/Process (E/P) Change Control actions in TrackWise or TrackWise Digital for QC Microbiology.

· Responsible for Standard Operating Procedure (SOP), MTM, and specification review, revision, and creation.

· Reviews documents for authorization and approval of required or necessary changes and ensures correctness and completeness.

o Reviews Microbiology documentation in accordance with FDA/USP/CFR Guidance; ensures reports, submission documentation, and development summaries for various processes are available for management review.

· Collaborates with other Microbiology Project Manager(s) to ensure coordinated initiatives are assigned and effectively communicated between all microbiology personnel.

· Communicates Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to the QC Project Manager, QC Microbiology Manager, Assistant Director of Microbiology, Director of Microbiology, or designee.

NOTE: The primary accountabilities above and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

Knowledge, Skills & Abilities:

• Bachelor’s degree preferred.
  • 1-2 years of pharmaceutical experience in Microbiology and/or Quality Systems preferred.
  • Associates degree required.

· 1 – 3 years of experience with MS Word, Excel, PowerPoint.

· 1 – 2 years project management and coordination experience.

· Strong interpersonal, verbal, and written communication skills; effective organization, multitasking, cGMP documentation, and problem-solving skills.

· Possesses the initiative and follow-through to implement, track, and achieve on-time completion of projects, as assigned by management.

· Ability to perform tasks successfully with minimal supervision. The ability to manage a multitude of resources and to be accurate and current with data and information.

· The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.

· Must strive for continuous improvement in all work activities.

· 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 set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.

· The ability and willingness to change direction and focus to meet shifting organizational and business demands.

· The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.

· Specific expertise, skills and knowledge within training and special projects 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.

· Salary range: Based on experience

· Hours of work: Monday thru Friday on an 8 hour shift, or as needed based on company demand.

EEO Statement:

Nephron 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.