Objective: Support the build-out and implementation of a complaint evaluation laboratory for an electromechanical pump. Coordinate cross-functional work across technical, quality, regulatory, engineering, facilities, laboratory, procurement, IT, and external partners to establish facility readiness, equipment and systems, processes, documentation, testing, training, and transition to routine operations.
Primary Functions: Lead day-to-day project management for the laboratory build-out. Build out and maintain the integrated schedule; coordinate governance, communications, deliverables, and decisions; manage risks, issues, and changes; and provide clear status reporting. Identify critical-path activities and dependencies, pursue opportunities to accelerate execution and reduce risk, and support project completion and operational handoff.
Key Responsibilities:
Build and maintain an integrated cross-functional schedule covering workstreams, milestones, dependencies, deliverables, estimates, owners, and decision points.
Identify and actively manage critical-path and near-critical activities; assess sequencing, constraints, and opportunities to accelerate or recover schedule while maintaining quality and compliance.
Coordinate laboratory build-out work, including facility readiness; equipment selection, procurement, installation, and qualification; laboratory systems; procedures and work instructions; quality/regulatory readiness; sample handling, testing, data management and reporting; training; and operational transition.
Establish meeting cadence and governance; schedule meetings, prepare agendas, facilitate discussions, document decisions and minutes, and maintain action logs with owners and due dates.
Track tasks, milestones, deliverables, and actions to closure; follow up on commitments and escalate overdue or at-risk items.
Prepare status reports, dashboards, milestone updates, and management communications.
Maintain risk, issue, action, and decision logs; assess impacts and coordinate mitigation, contingency, and recovery plans.
Monitor scope, schedule, resources, assumptions, and dependencies; support change control, budget/resource tracking, and leadership escalations with options and impact assessments.
Coordinate internal teams and vendors, contractors, suppliers, and consultants as needed.
Support closeout, including deliverable confirmation, outstanding actions, lessons learned, documentation completion, and transition to laboratory operations.
Qualifications:
Bachelor’s degree in project management, engineering, science, business, operations, or a related discipline; equivalent experience may be considered.
Experience managing complex, cross-functional projects in a regulated technical, laboratory, pharmaceutical, medical device, manufacturing, or life sciences environment.
Experience developing integrated schedules and managing project governance, meetings, action tracking, status reporting, and risks/issues.
Strong communication, organization, facilitation, and problem-solving skills.
Ability to identify critical paths and drive mitigation, acceleration, and recovery actions.
Ability to work effectively with technical, quality, facilities/engineering, laboratory, procurement, IT, vendor, and senior stakeholder groups.
Ability to work independently in remote and office-based settings.
Preferred Qualifications:
PMP, CAPM, or equivalent project management certification.
Experience with laboratory construction, renovation, commissioning, qualification, validation, or operational readiness.
Experience with complaint handling, product quality, laboratory testing, investigations, or post-market surveillance.
Experience in GLP, GMP, or a similarly regulated environment.
Experience managing external contractors, equipment suppliers, laboratory service providers, or other third parties.
Familiarity with change control, quality systems, validation documentation, inspection/audit readiness, and geographically distributed teams.
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $70.00/hr - $75.00/hr.
