Monroe, NC
Posted:

Job Description

Position Summary

This position will be an SAP site user that manages material codes and approved vendors. This position will additionally serve as a creator of the specifications and test procedure utilized on site to test and release materials and products. Will be working within the Company Quality Systems & Compliance group supporting the development and implementation of harmonized processes and systems. This position will actively participate in global procedure harmonization and other Quality System projects as needed. Position will report to Quality Assurance Supervisor. Responsibilities are detailed below in job responsibilities section.

Major Responsibilities

  • Manage quality information for all site materials within SAP
  • Creation of site-specific specifications, standard test procedures, and certificates of analysis
  • Maintain quality system controls to ensure state of compliance
  • Contributes to continual improvement at a team and site level
  • Participates in maintaining compliance at a site level

Education

  • Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent

Qualifications

  • Minimum of 2 years of experience in related field
  • Previous GMP experience is required
  • Previous experience in quality, sterile manufacturing, or regulatory affairs is preferred
  • Any professional certification a plus
  • Experience using SAP and MasterControl is preferred

Knowledge & Skills

  • Must be proactive, results oriented, with a strong attention to detail
  • Should have experience utilizing electronic quality systems (i.e. MasterControl) and ERP software (i.e. SAP)
  • Understands pharmacopeia requirements for testing and release of raw materials, packaging materials, and drug products
  • Displays ability to compare information from different sources to propose an appropriate course of action
  • Can manage multiple assignments simultaneously, meet deadlines, and handle an ever-changing, fast-paced environment
  • Must have strong interpersonal skills to be able to interact with all level of personnel in a profession and constructive manner.
  • Works well in a team environment and able to collaborate with individuals from other functional areas
  • Able to clearly communicate both verbally and in writing
  • Strong communication skills
  • Ability to manage competing priorities

Work Schedule

Monday – Friday 0800 to 1700 (8:00 AM – 5:00 PM)

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