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QA Strategy & Operations Coordinator in Bernards, NJ at DSI

Date Posted: 2/28/2019

Job Snapshot

Job Description

Job Summary:

Position is responsible for routine support at the local organizational unit and cross-organizational level. This position performs support tasks in which incumbents are expected to understand and apply knowledge of the complexity of the organization. This position has considerable latitude to make decisions without supervisor approval and solves problems while carrying out assigned tasks. Additionally, this position is responsible for upholding a strong commitment to confidentiality and routinely handles sensitive documents that may impact multiple organizational units or project teams. This position has advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills in database and research tools.

Responsibilities:
  • Administrative support includes but not limited to: Responsible for travel, Financial Administration as needed (e.g. tracking of expenses for travel and office space), meeting arrangements for Head of Group and other associates as applicable. Handling of confidential documents (salary, performance review, reorganization)
  • Ensure ordering of office material and other relevant equipment
  • Manage Calendar for Head of LT QA functions and ensure an organized approach
  • Support the Director QA strategy and operations on projects needing to be coordinated within QA, ensure that teams are adequately engaged to deliver as expected and escalate any delays to Head of Group and / or Director strategy and operations.

Support Operational activities:
  • Manage the QA shared point and ensure that information provided is accurate and reflects on going activities. Regularly check the site for accuracy, up to date information, and links as well as compile new content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate
  • In collaboration with the head of Strategy, Collate and produce accurate and timely reports as needed pertaining to QA activities
  • In collaboration with Executive admin, ensure QA org charts, team lists, projects assigned to individuals are current and up to date
  • Support regulatory inspection related activities as required such as organizing CAPA coordination teams, ensuring logistics for inspections, ensuring team list for QA pertinent to inspections are maintained including, training, CVs, JDs
  • Collect, store and maintain all auditable documentation as per DSI Internal control
  • Distribute reports as necessary to the QA teams and ensure on time organization communication is cascaded to the teams for awareness.
  • Recruitment support: Independent handling of personnel request forms, coordination of the interview program and process with HR and candidates. Mange all infrastructures; arrange introductory programs and trainings for newcomers.

Physical Requirements:

Shipping out large packages/boxes. Moving/arranging file folders in large quantities.

Qualifications:

Education: High school diploma or equivalent required, Associate degree preferred; or equivalent work experience.

Experience:

Typically requires 5 – 7 years of prior experience
Experience in Operational support role and relevant additional career training
Broad understanding of Health Authority expectations in the areas of Pharma Development; preferably working in a GxP regulated environment, pharmaceutical industry.
Training and curricula development experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality management systems.
Strong interpersonal, communication, negotiation and problem solving skills.
Organizational awareness (e.g. inter-relationships of departments, business priorities), including experience working cross-functionally and in global teams.
In depth knowledge and working experience with common computer software programs, i.e. MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project)

Competencies (Optional):

Effective planning and execution of operational activities needed in QA
Accurate and timely overview on project
Accurate and up-to-date share point page for QA
Adequate collaboration with HR and effective support of the recruitment process
Efficient travel coordination
Very good written and spoken English.
Knowledge of other languages an advantage