About The Position

Our Quality Control group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Requirements

  • Proficient with Microsoft Word and Excel
  • Ability to work with others on a team
  • Accountability for own actions, and ability to prioritize
  • Knowledge of regulatory and current GMP principles

Nice To Haves

  • Operating laboratory equipment: HPLC, dissolution apparatus, KF, etc.
  • Utilizing Empower | Labware/LIMS
  • Execution of root cause analysis
  • Background in technical writing including but not limited to: updating of standard operating procedures and writing quality notifications
  • Knowledge of Tier processes
  • Executing 5S principles

Responsibilities

  • Employee must show ability to perform routine assignments and develops competence by performing structured work assignments
  • Ability to use existing procedures to perform routine testing
  • Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues that may impact other functions
  • Builds and promotes the Team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives
  • Demonstrates understanding of customer needs, requirements, and expectations
  • Seeks new ways to improve services to customers
  • Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging Team members to make suggestions and share ideas
  • Works to develop new skills and abilities
  • Readily accepts performance feedback and incorporates this feedback into future performance
  • Assists other Team members, including helping with developmental activities
  • Learns to use new problem-solving tools to surface and solve issues
  • Applies general knowledge of company business developed through education and past experience
  • Ability to interpret our Company Quality Policies, Guidelines and Testing Procedures for daily application
  • Understands and applies regulatory/compliance requirements, including Good Manufacturing Practice (GMP), Non-Disclosure Agreement (NDA), and related regulations, and has the ability to interpret those regulations for implementation in the workplace
  • Possesses a basic knowledge of theories, practices, and procedures in the Quality Control discipline, including the knowledge and understanding of pharmaceutical testing
  • Active with developing technical writing capabilities and is able to compile straightforward investigations and procedures, and recommend scientifically sound corrective actions
  • Possesses a basic knowledge and ability to operate lab instrumentation required to complete job responsibilities
  • Uses existing procedures to perform routine testing
  • Ability to independently respond to basic requests for data and trending of data
  • Communicates information and asks questions to check for understanding
  • Develops small scale presentations and presents to own work Team or small groups with the assistance of others
  • Limited decision-making authority and works within technical guidelines/direction to achieve objectives and meet deadlines
  • Accountable for technical contribution to work or project Team

Benefits

  • medical
  • dental
  • vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
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