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Operations Technician I - Secondary Packaging (Multiple Shifts Avail.)

Nephron Sterile Compounding Center LLC

West Columbia, SCOnsitePosted 1 day ago
Full TimeEntry LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

Secondary Packaging's main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products.

Job description

Job Purpose

Secondary Packaging's main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products.

Essential Duties and Responsibilities

  • Operate the Secondary Packaging equipment and determine trends (i.e. vials per minute and pallets packaged per shift).
  • Responsible for changeovers and end of lot procedures.
  • Responsible for documenting in the MBR.
  • Responsible for operating and repairing minor problems with Secondary Packaging equipment.
  • Responsible for clearing machine jams and minor adjustments.
  • Perform line clearances, machine challenges, exhibits, and startup checklist.
  • Perform cleaning, vacuuming, and other housekeeping duties to maintain a high level of cleanliness of the Secondary Packaging lines.
  • Be familiar with Autoclave process.
  • Be familiar with Laser Guided Vehicles (LGVs) and know how to clear faults.
  • Monitor waste and make adjustments to product placement as needed. Be able to maintain pouch appearance accordingly.
  • Verify lot number and expiration dates are correct.
  • Ensure labeling is neat and correctly placed on all products.
  • Follow the instructions of the paper Master Batch Record or the Electronic Batch Record.
  • Read and understand all Standard Operating Procedures for the tasks you are performing.
  • Perform additional work duties or responsibilities as evident or required.

Supplemental Functions

  • Work under the direction of the Secondary Packaging Shift Supervisor or designee.
  • Assure the efficient performance of all department equipment.
  • Assist with housekeeping as needed.
  • Adhere to GMPs and hold those around them accountable.

Job Specifications and Qualifications: Knowledge & Skills

  • Knowledge of the Pharmaceutical or Manufacturing Industry preferred
  • Must be able to pass a drug screening.
  • Must read, write, and speak English fluently.
  • Specific expertise, skills, and knowledge gained through education and experience.
  • The ability to take strategic objectives and accept accountability to drive results through effective actions.
  • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  • The ability to effectively manage ones self, demonstrates integrity, be productive under pressure, and achieve development goals.
  • The ability to create new products and processes that add value to the Business by generating new ideas and applying creative and analytical approaches.
  • Incumbents required to wear safety glasses, hearing protection, and other non-specified protective equipment as necessary.
  • Salary range: based on experience.
  • Available to work on-call per management's request.
  • Must be able to work well with others.

Education/Experience

  • High school diploma or equivalency is required. 1 year of manufacturing or pharmaceutical experience preferred, but not required.

Requirements

  • High school diploma or equivalency required
  • Must be able to pass a drug screening
  • Must read, write, and speak English fluently
  • Available to work on-call per management's request
  • Must be able to work well with others
  • Knowledge of the Pharmaceutical or Manufacturing Industry preferred
  • 1 year of manufacturing or pharmaceutical experience preferred, but not required

Company overview

Nephron Sterile Compounding Center LLC is a leading 503B outsourcing facility specializing in sterile pharmaceutical compounding and manufacturing. Based in West Columbia, South Carolina, the company operates as a registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act, focusing on the production of sterile, preservative-free respiratory inhalation medications and other compounded drug products. The company serves a diverse customer base including hospitals, retail pharmacies, long-term care facilities, home care companies, and mail-order pharmacies. Nephron specializes in manufacturing generic respiratory medications used in the treatment of asthma and COPD, as well as producing sterile pre-filled medications, small-volume parenteral solutions, and IV bags. The facility utilizes advanced sterile manufacturing technologies and maintains cGMP-compliant operations with a high-purity water system capable of consistently providing Water for Injection. As an outsourcing facility, Nephron addresses drug shortages by manufacturing products in short supply, with capabilities including blow-fill-seal technology and aseptic processing. The company has faced regulatory scrutiny from the FDA regarding sterility assurance and compliance with 503B requirements, leading to voluntary recalls and ongoing compliance activities. Despite these challenges, Nephron remains a significant employer in the Lexington County area and continues to play a role in the sterile compounding pharmaceutical sector.

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