Microbiology QC Data Specialist

Description

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:

• Provides      data analysis, tracking and trending, review, and updates for the Quality      Control (QC) program and product release through use of LabVantage, MODA,      and PowerBI systems. 
• Creates      and executes project work plans and revisions as appropriate to meet      changing needs and requirements.
• Updates      procedures and documents pertaining to data acquisition, sample review, or      result trending for the QC Microbiology Laboratory.
• Completes      investigations pertaining to QC data as necessary and implement any      corrective or preventive actions deemed necessary. 
• Assists      with implementation and review of QC Microbiology specifications.

· Works closely with QC Microbiology management and sample management team to ensure timely review of all laboratory data.

• Assists      with QC Microbiology projects as deemed necessary by members of      Microbiology Management. 

· Performs job duties with minimal supervision.

Primary Accountabilities:

· Responsible for reviewing microbiology laboratory data reported using LabVantage, MODA, and/or paperwork

· Complete Data Integrity Risk Assessments for applications used by the QC Microbiology team, as needed.

· Ensure accuracy when generating data from LabVantage, MODA, Power BI, and other applications/databases for Microbiology projects, trend analysis, and investigations. 

· Review QC data and perform trend analysis utilizing LabVantage, MODA, and/or PowerBI systems. 

· Establish/maintain a system for reviewing any results reported on paperwork and ensure results are properly trended. 

· Help establish alert levels or trend limits for sample results based on historical analysis. 

· Assist in trending of microorganisms.

· Assist with training individuals on accurate data entry and use of LabVantage, MODA, and PowerBI. 

· Assist with establishment of timelines for each phase of QC projects, as well as a completion date for entire projects as assigned.

· Provide Standard Operating Procedure (SOP) reviews, revisions, and creation, as necessary.

· Assists in investigations pertaining to QC Microbiology, as needed, and ensures completion in a thorough, timely manner. 

· Communicate QC-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to Microbiology management.

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 are documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

Knowledge, Skills & Abilities:

• Bachelor’s degree in Microbiology, Chemistry, or      Information Systems, preferred. 
  • 1-2 years of data analysis experience in pharmaceuticals       or comparable health organizations, preferred. 
  • 1-2 years of pharmaceutical experience in quality       systems preferred.
  • Experience and education outside of pharmaceuticals in       data systems, microbiology, or R&D will be considered for highly       qualified candidate. 

· 1-3 years of experience with data management systems.  

· Proficient in Microsoft Suite; specifically, proficiency in Microsoft Excel required.  

· Great communication, documentation, computer, and time management skills. Must be able to multitask. 

· Must possess excellent analytical skills and problem-solving ability, strong attention to detail, sound understanding of cGMP regulations pertaining to data integrity and laboratory controls, and a thorough knowledge of USP and CFR standards. 

· Ability to utilize statistical tools to identify, analyze, and interpret patterns and trends in complex data sets. 

· 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 to drive results through effective actions.

· 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.

· Specific expertise, skills and knowledge related to microbiology through education and experience.

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

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

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

· The ability to create new processes that add value to the Business, by generating new ideas and applying creative and analytical approaches.

· A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.

· 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, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.