Job Information: Assistant to the Operations Leader Job

The Assistant to the Operations Leader keeps Instant Systems' operations leadership organized and its improvement and growth projects on track. Half of the role supports the Operations Leader directly: calendar, communications, meetings, reporting and audit logistics. The other half plans, tracks and drives operations projects, such as capacity expansions, new cleanroom or line start-ups, equipment installations, Lean programs and system upgrades, working with Production, Engineering, Quality, Supply Chain, EHS and Finance. The role is a strong development path toward a Project Manager or Operations Manager position.

Responsibilities:

- Manage the Operations Leader's project portfolio: keep a single list of active and planned projects with owner, scope, budget, status, risks and next milestone.
- Build project charters, scopes, work breakdown structures and schedules (Gantt charts) with project owners.
- Run project kick-offs and recurring project meetings; publish agendas, minutes, decisions and action items, and follow up until closed.
- Track milestones, dependencies and critical paths; flag slippage early and propose recovery options.
- Maintain RAID logs (risks, actions, issues, decisions) and escalate risks to the Operations Leader with a recommended response.
- Track project budgets and capital spend (CapEx) against plan with Finance; prepare capital request paperwork and route it for approval.
- Prepare weekly project status reports and a monthly portfolio dashboard (e.g., red/amber/green status, schedule and budget variance).
- Coordinate project resources: internal teams, contractors, equipment vendors and consultants, including quotes, purchase requests and site access.
- Close projects with lessons learned, final budget reconciliation and handoff to the owning department.
- Manage smaller projects end to end, such as office or area layout changes, 5S rollouts, training rollouts or reporting improvements.
- Make sure projects that touch product, processes, equipment or facilities go through change control before implementation.
- Coordinate validation deliverables with Engineering and Quality: user requirements, IQ/OQ/PQ protocols and reports, and cleanroom qualification (ISO 14644) where applicable.
- Track document updates (SOPs, work instructions, forms) and training that must be complete before go-live.
- Keep project records organized and audit-ready in line with ISO 13485:2016, FDA 21 CFR Part 820 and Good Documentation Practices.
- Manage the Operations Leader's calendar, prioritizing and resolving conflicts across internal meetings, customer visits, supplier calls, audits and travel.
- Screen emails and requests; respond on the Operations Leader's behalf where appropriate and escalate what needs attention.
- Draft correspondence, memos, announcements and presentations for internal and external audiences.
- Arrange travel and process expense reports.
- Handle confidential business, customer and personnel information with complete discretion.
- Coordinate the operations leadership rhythm: weekly staff meetings, monthly operations reviews, quarterly business reviews and annual planning.
- Compile weekly and monthly operations KPI reports (e.g., output, on-time delivery, yield, scrap, safety, headcount, overtime) from ERP/MES and department inputs.
- Prepare PowerPoint decks for leadership, board and customer presentations.
- Coordinate logistics for FDA inspections, notified body audits and customer audits: schedules, war room and back room setup, document request tracking and escorts.
- Plan customer and supplier visits, including agendas, plant tours, gowning and cleanroom entry, safety briefings and confidentiality agreements.
- - Other Responsibilities
    - As assigned

To be considered you’ll need:

Bachelor's degree in Business Administration, Operations or Supply Chain Management, Engineering, Project Management or a related field.
3–5 years of combined experience in project coordination or project management and administrative or operations support.
experience in a manufacturing, medical device, pharmaceutical, biotech or other regulated environment.
hands-on experience building project schedules, tracking action items and budgets, and reporting status to leadership.
working knowledge of project management methods (scope, schedule, cost, risk, stakeholder management), for example from PMI PMBOK practice.
advanced skills in Microsoft 365: Outlook, Word, Excel (pivot tables, charts, lookups), PowerPoint and Teams/SharePoint.
experience with at least one project management tool (e.g., MS Project, Smartsheet, Planner, Asana, Monday.com).
excellent written and verbal communication, strong organization and attention to detail.
demonstrated discretion with confidential information.
solid company-centric ideology.
creative problem-solving skills.
the ability to balance multiple priorities.
core values of honesty and respect.
a thirst for learning.
the desire to be challenged.

Applicants for this position must successfully pass background, drug screen and reference check. It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.


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