Document Control Specialist Jobs

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, with additional distribution centers in Kentucky and Arizona. 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:

• Create and maintain standard operating procedures, change control records, and documentation in accordance with cGMP while assisting as needed in any aspect of the document control process.
• Provide support for the Quality Management System.
• Requires copying, filing, and scanning.
• Assists with additional work duties or responsibilities as evident or required.
• Ability to learn and perform Document Control functions.
• Flexibility to work overtime and weekends, if required.
• Utilization of Laboratory Information Management System (LabVantage), SharePoint, and TrackWise® software systems.
• Organization and time management techniques using tools like Microsoft Outlook calendar, reminders, and task lists.
• Prepare and verify electronic and paper batch records.

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. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• Perform batch record generation for NPC and 503B: range 3 - 10 per day depending on type.
• Maintain original and working copy binders to ensure they contain the latest effective revisions.
• Email and TrackWise Activities
• Assist with document accuracy including, but not limited to: formatting headers and footers, spelling corrections, appropriate grammar and punctuation, consistent fonts and numbering sequences, etc.
• Review production schedule to determine what needs to be performed.
• Average time frame per 503B batch record: Paper MBR: 45 mins – 1 hr.; EBR: 20-30 mins.
• Create batch IDs using LabVantage.
• Route new and revised controlled documents (forms, master batch records, SOPs, test methods, work instructions, etc.) using SharePoint (document management and storage) and Trackwise® (change control) software systems.
• Promptly respond to TrackWise request: Obsolete, grant permissions, schedule SMEs, implementation, send to training, etc.
• Perform monthly audits to ensure the correct version of effective documents is in binders and used in preparing batch records.
• Manage and maintain document archive process.
• Average time frame per NPC MBR; Filling: 1.5 – 2.0 hrs.; Secondary Packaging: 45 mins. – 1 hr.)
• Update Master Distribution List and Table of Contents with current and approved document’s number, title, and effective date.
• Promptly respond to 8 – 20 request per day for emails and TrackWise
• Maintain LIVE DOCs to ensure they contain the latest effective revisions.
• Promptly respond to email request including but not limited to: Logbook issuance and return process, Regulatory request, audit request, 2nd issuance, permissions, etc.
• Assist with the preparation and verifying of batch records as demanded by the Production Schedule:

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.

Knowledge, Skills & Abilities:

NOTE: The knowledge, skills and abilities 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.

• Specific expertise, skills, and knowledge within document control gained through education and experience.
• 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 demonstrate integrity, be productive under pressure, and achieve personal and department goals.
• Strong written and oral communication skills
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Office experience is preferred (typing, filing, and scanning).
• Attention to details to minimize the risk of errors.
• Effective time management skills including prioritizing and scheduling.
• Position requires typing, lifting, vision (20/20), standing (15%), sitting (42.5%), walking (42.5%), talking, and hearing.
• Salary range: Based on experience
• Hours of work: Monday thru Friday on an 8-hour shift, one evening per week till approximately 7 pm, and rotating on-call weekend coverage (on-call average once every 8 weeks).
• Proficient computer skills with Microsoft Word, Excel, and Outlook.
• Minimum of 1 year in the pharmaceutical industry preferred.
• Regionally accredited business-related degree or equivalent work experience.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• Ability to work independently and as part of a team.