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Quality Applications Specialist

3 months ago

Dexter, United States Three Point Solutions Full time
Job DescriptionJob Description

Job Title: Quality Applications Specialist

Client: Medical Device Manufacturing Industry

Duration: 12 Months

Location: Dexter, Michigan 48130

Shift: 1st Shift

Technical Skills

Must Have:

  • Investigation and root cause analysis skills
  • Technical writing knowledge
  • Organization and communication skills
  • Process validation and computer software validation knowledge
  • Advanced SQL Server skills
  • Database server administration
  • Manage MS SQL

Nice to Have:

  • Certified in CSV (Computer System Validation)

HM's Top Needs:

  • Quality/CSV Validation experience
  • ERP/MS SQL database experience
  • IT System Administrator experience

Experience: 2-7 years

Responsibilities:

  • Conduct a compliant validation process for quality information technology systems requiring formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  • Coordinate activities with clients, programmers/developers, and operating personnel, domestically and globally, as appropriate.
  • Identify current and anticipated requirements for compliant computerized operations and suggest methods for identification, implementation, and maintenance of procedures, actions, and documentation necessary to assure compliance with appropriate federal and international regulations governing the user's applications.
  • Report on the status of validation activities to fulfill regulatory requirements.
  • Stay abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
  • Perform system administration and configuration of quality information technology systems.

Specialist Career Stream:

  • Typically an individual contributor with responsibility in a professional discipline or specialty.
  • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
  • May act as a mentor to colleagues or direct the work of lower-level professionals.
  • Majority of time is spent delivering and overseeing projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors:

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
  • Innovation and Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.
  • Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience:

  • Requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience.
  • Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.

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