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Quality Assurance Auditor, Retains, Sampling And Staging

Expired Job

Mayne Pharma Group Limited Greenville , NC 27833

Posted 3 months ago

Position Overview

This position requires the ability perform established routine and non-routine Quality Assurance tasks with supervision in support of commercial processes and projects as assigned.

Key Responsibility Areas

  • Data Integrity: Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities

  • Quality Advocacy: Provides broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization

  • Safety: Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organization

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function

  • Perform the sampling of all commercial labels and topserts

  • Interface with appropriate Warehousing, Planning, and Operations departments, for the staging of all labels and topserts for commercial packaging

  • Perform quarterly inventory count verifications and annual inventory counts for labels and topserts and resolve any discrepancies

  • Staging of all labels and topserts for commercial packaging and perform quarterly inventory count verifications and resolve any discrepancies

  • Responsible for managing the Commercial Quality Site Retain Program: filing samples, pulling samples for requests, conducting annual retain inspection and managing the retain sample life cycle though destruction

  • Become proficient in pertinent computer systems (i.e. QAD, MasterControl, etc.)

  • Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs

  • Provide backup support by performing manufacturing and packaging room clearances and in-process QA checks; assuring release of raw materials and components prior to manufacturing/packaging; providing real-time support activities for production lines

Key Competencies/Requirements

  • Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others

  • Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems

  • Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services

  • Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates

  • Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas

  • Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people

  • Attention to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled

  • Communication: Deliver clear, effective communication and take responsibility for understanding others

  • Teamwork: Work well with others while providing support and assistance to team members to help accomplish objectives

  • Time Management: Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity

Qualifications

  • Associate's degree with three years of professional experience in the pharmaceutical industry

  • Bachelor's degree with two years of professional experience in the pharmaceutical industry

  • A combination of education and experience that may be considered equivalent

Physical Requirements

  • Some exposure to hazardous chemicals and other active chemical ingredients

  • Capacity to handle and manipulate objects using hands and arms

  • Position requires the capacity to handle and manipulate objects using hands and arms and able to lift 25-50 pounds

General Statement

Mayne Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.


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Quality Assurance Auditor, Retains, Sampling And Staging

Expired Job

Mayne Pharma Group Limited