Antares Pharma: Making Medicines Feel Better

Quality Systems Specialist

POSITION SUMMARY:

The Quality Systems Specialist is responsible for the administering and maintaining document management, change control, and training processes. This role will primarily focus on maintaining the Quality Management Systems (QMS) document and records archive at the Minnesota facility via participation in facilitating the change control process. The Quality Systems Specialist will maintain a strong collaborative partnership with cross-functional team members that facilitate organizational success by protecting patient/user safety and meeting business needs. Employees in this role are empowered to act on their strong desire to make a difference, partner with others, and put ideas into action. Additionally, they should be engaged by a work culture that is team-oriented, fast paced, and progressive.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

  • Coordination with pertinent internal functional groups as needed to facilitate timely processing of new documents, document changes, and change controls.
  • Reviews internal documents prior to issuance to confirm it satisfies expected Antares Pharma standards; works with document authors to resolve deficiencies.
  • Administration of the training management system, ensuring training is assigned and deployed to employees.
  • Actively collaborates with department leaders to create training plans for new and changed positions within the organization.
  • Delivers training to employees on the use of Electronic Quality Management Software (eQMS) for training, document control, and change control systems.
  • Responsible for entering new suppliers into Enterprise Resource Planning system (ERP). Creates materials and bills of materials in ERP system.
  • Drives periodic review of training plans with department leaders to ensure training plans are appropriate and relevant.
  • Preparation and reporting of quality metrics related to document control, training, and other processes as needed.
  • Maintaining document and record archive, facilitating transfer and retrieval of documents and records stored at off-site locations.
  • Performing duties in accordance with the Company’s Quality Systems and with standard operations procedures (SOPs) that are consistent with regulatory requirements and industry standards.
  • Compiles and issues on-site product batch records.
  • Administration of QMS record storage, including organization and retrieval of records stored at Minnesota site and off-site storage.
  • Leads review of retained records for transfer to off-site locations or disposal.
  • Creates metric reports for document control, change control, and training systems as required. Supports the administration of the eQMS.
  • Generating reports for management and inspections, as requested.
  • Support audits (internal, client, due diligence, regulatory).
  • Management of external documents, including those maintained through subscription services.
  • Administrates the review of internal documents according to planned arrangements and external documents upon notification of update release.
  • Provides input to support the continual improvement of document control, record management, and training administration processes.
  • Participation in projects as a team member, as needed.
  • Performing other related duties, as assigned.
  • Participation in projects as a team member, as needed.

EDUCATIONAL REQUIREMENTS (degree, license, certification):

  • Minimum two years of college or work experience equivalent.

YEARS OF EXPERIENCE:

  • 3 or more years in medical device or pharmaceutical document management, change control management, or training administration systems.

OTHER SKILLS AND ABILITIES:

  • Strong computer skills. Fluent with Microsoft Office business software and use of information databases, particularly Microsoft Word, PowerPoint t, and Excel.
  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives, and guidance.
  • Experience with eQMS software for document and record management and training administration.
  • Experience with ERP software systems.
  • Familiarity with CAD software and reading of technical drawings.
  • Experience with document indexing structures, scanning, and high-volume printing.
  • Proven ability to communicate effectively; orally and written.
  • Ability to manage multiple tasks and projects, using negotiation skills to push tasks to completion.
  • Able to work independently, as well as in a cross-functional team environment.
  • Experienced with participation in audits.
  • Customer Service oriented attitude and ability to exercise sound business judgment.
  • Ability to maintain confidentiality and discretion in business relationships.

Apply To: Careers@Antarespharma.com

Careers

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