Nephron Nitrile Document Control Specialist

Corporate Statement

Nephron Nitrile is a new privately-owned Nitrile Glove manufacturer. Nephron Nitrile products are proudly made in the USA! We are headquartered in West Columbia, South Carolina. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability.

Position Summary:

• Utilization of Laboratory Information Management System (LabVantage), SharePoint, and TrackWise Digital® software systems. Prepare and verify batch records.
• Ability to learn and perform Document Control functions.
• 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.
• Requires copying, filing, and scanning.
• Flexibility to work overtime and weekends, if required.
• Assists with additional work duties or responsibilities as evident or required.
• Provide support for the Quality Management System.
• Organization and time management techniques using tools like Microsoft Outlook calendar, reminders, and task lists.

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.

• Manage and maintain document archive process.
• 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.
• Maintain original and working copy binders to ensure they contain the latest effective revisions.
• Perform batch record generation for Nephron Nitrile
• Maintain LIVE DOCs to ensure they contain the latest effective revisions.
• Review production schedule to determine what needs to be performed.
• Route new and revised controlled documents (forms, batch records, SOPs, test methods, work instructions, etc.) using SharePoint (document management and storage) and TrackWise Digital® (change control) software systems.
• Email and TrackWise Activities
• Update Master Distribution List and Table of Contents with current and approved document’s number, title, and effective date.
• Assist with the preparation and verifying of batch records as demanded by the Production Schedule:
• 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 document accuracy including, but not limited to: formatting headers and footers, spelling corrections, appropriate grammar and punctuation, consistent fonts and numbering sequences, etc.

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.

• Strong written and oral communication skills
• Specific expertise, skills, and knowledge within document control gained through education and experience.
• Regionally accredited business-related degree or equivalent work experience.
• 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).
• 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.
• Salary range: Based on experience
• Position requires typing, lifting, vision (20/20), standing (15%), sitting (42.5%), walking (42.5%), talking, and hearing.
• Attention to details to minimize the risk of errors.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• Minimum of 1 year in the pharmaceutical/medical device industry preferred.
• Hours of work: Monday thru Friday on an on an 8-hour shift, or as needed based on company demand.
• Proficient computer skills with Microsoft Word, Excel, and Outlook.
• The ability to demonstrate integrity, be productive under pressure, and achieve personal and department goals.
• Ability to work independently and as part of a team.
• Effective time management skills including prioritizing and scheduling.

EEO Statement:

Nephron Nitrile 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 Nitrile is a drug free workplace.