Quality Systems Specialist

About the role

Candidate will be expected to work within the Quality team as the specialist for Computer System Validation. Responsibilities will focus on Manufacturing and Laboratory work, including reviewing and approving validation/qualification protocols and reports, standard operating procedures, investigations, work orders, change documents, and project reports.

Responsibilities

• Provide quality and compliance oversight for the qualification and validation of manufacturing, laboratory, and testing processes.
• Review and approve qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and applicable acceptance criteria.
• Provide quality and compliance oversight for the commissioning and qualification of site facility spaces and utilities.
• Review and approve Change Controls, Project Validation Master Plans, Commissioning Test Plans, Qualification protocols, SOPs, and Summary Reports.
• Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility.
• Review and approve documentation supporting Plant and Laboratory Maintenance, including planned (Preventative Maintenance) and unplanned (work orders and change controls) maintenance for equipment and instruments.
• Review and approve Risk Assessments, Change Controls, SOPs, FMEA, Periodic Qualifications, Project Plans, and Master Plans.
• Manage multiple and complex projects, provide status reports, and coordinate with other departments and/or outside contractors/vendors to complete validation tasks.
• Exercise judgment and problem-solving to define decision criteria and determine the most appropriate course of action.
• Demonstrate planning and organizational skills to establish objectives and schedule tasks/resources efficiently.
• Support technical and quality investigations to resolve issues.
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.

Skills

• Validation
• GMP
• Change Control
• Deviation
• LIMS
• Electronic Notebook
• Data integrity
• Data management
• Computer system validation

Requirements

• 3–5 years of relevant experience or equivalent.
• Bachelor’s degree in a Science-related field or equivalent experience.
• Experience in writing and revising documentation.
• Proficiency with Microsoft Word, Excel, and Outlook.
• Proficiency in Change Control and Deviation.
• Ability to work effectively as part of a team and exhibit effective interpersonal skills.
• Strong oral and written communication skills.
• Experience working within a GMP or GLP environment.

Pay

The pay range for this position is $50.00 – $65.00/hr. Individual compensation will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short- and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation, or Sick Leave)

Schedule

This is a hybrid position based in Philadelphia, PA.