Quality Control Microbiology Project Manager

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 Control Microbiology Project Manager creates and executes Quality Control Microbiology project work plans and revises, as appropriate, to meet changing needs and requirements of the department. Manages daily operational aspects of Product Development Studies, Equipment Validations, testing procedures, SOPs, and other documents, as needed, and reports project status to upper management. Creates and assigns project review plans; ensures timely completion of all assigned special projects to meet changing needs, requirements, and deadlines of QC Microbiology. Ensures operational efficiencies and works on continuous improvement efforts. Assist with and tracks QC Microbiology related investigations and trending reports to ensure completion in a timely/effective manner. Ensures appropriate corrective/preventive actions performed by the QC Microbiology team are implemented appropriately and performed within a timely manner. Assists and tracks associated change controls and procedure updates related to QC Microbiology documents and processes. Assists with managerial review of QC Microbiology samples to ensure samples are processed for release/final disposition.

Essential Duties and Responsibilities:

• Oversees the review of Microbiology documents in the laboratory including logbooks, laboratory notebooks, hood cleaning binders, and others as assigned.
• Conducts 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.
• Completion of projects and/or ownership of project tasks as assigned or required to meet company objectives.
• Identifies discrepancies and initiates updates to procedures (DOT compliance); assists in coordination of Equipment/Process (E/P) Change Control actions in DOT compliance for QC Microbiology.
• Authors and/or reviews Microbiology related protocols, summary reports, and related documentation as assigned.
• Responsible for Standard Operating Procedure (SOP), MTM, and specification review, revision, and creation.
• Identifies operational and training improvements for QC Microbiology personnel and follows them through to completion.
• Reviews documents for authorization and approval of required or necessary changes and ensures correctness and completeness.
• Collaborates with other Microbiology Project Manager(s) and Management 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 QC Microbiology Manager, Director of Microbiology, Vice President of Microbiology, or designee.
• Authors and reviews QC Microbiology related investigations such as Deviations, MSSFIRs, and Excursions.
• Performs and assists with generation of the Microbiology Laboratory Trending of Microbial Recoveries quarterly trend report.

Supplemental Functions:

• Performs other duties as assigned.

Job Specifications and Qualifications: (can include licensure and certification requirements if applicable)

Knowledge & Skills:

• 1 – 3 years of experience with MS Word, Excel, PowerPoint.
• 1 – 2 years 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 oneself, 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.

Education/Experience:

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

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
• Salary range: Based on experience.
• Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demand.

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