QA Specialist

Job Title:

QA Specialist

Job Description

The Facilities Quality Assurance Specialist is responsible for providing quality oversight and support for facility, utility, and equipment-related activities within a GMP-regulated manufacturing environment. This role ensures that facility systems, maintenance activities, calibration programs, and quality system records comply with internal procedures, GMP requirements, and applicable regulatory standards. The ideal candidate will have hands-on experience authoring and reviewing Change Controls, CAPAs, and Deviations/Investigations, along with experience supporting facility and equipment quality systems.

Responsibilities

+ Author, review, and approve Change Controls related to facilities, utilities, equipment, preventive maintenance, calibration, and infrastructure upgrades.

+ Lead or support deviations, non-conformances, and investigations related to facilities, utilities, environmental systems, and equipment performance.

+ Initiate, track, and support closure of Corrective and Preventive Actions (CAPAs) to ensure timely and effective resolution of quality events.

+ Assess the impact of facility/equipment-related issues on product quality, validation status, and GMP compliance.

+ Ensure all quality records are accurate, complete, and inspection-ready.

+ Provide QA oversight for GMP facility operations, including HVAC, purified water systems, compressed gases, clean rooms, and other critical utilities.

+ Review and approve maintenance, calibration, and qualification documentation for GMP equipment and facility systems.

+ Partner with Facilities, Engineering, Validation, Manufacturing, and Quality Control to ensure changes to equipment and utilities are properly evaluated and documented.

+ Support quality oversight of contractors, vendors, and service providers performing work on GMP systems.

+ Utilize Blue Mountain software to review, track, and maintain calibration, preventive maintenance, and asset lifecycle records.

+ Ensure assets within Blue Mountain are maintained in a compliant state with accurate statuses, due dates, and historical documentation.

+ Support periodic reviews and audits of calibration/maintenance records within Blue Mountain.

+ Coordinate with Facilities and Metrology teams to ensure timely execution of calibration and PM activities.

+ Maintain knowledge of current GMP regulations, internal SOPs, and applicable regulatory expectations related to facilities and utilities.

+ Participate in internal audits, regulatory inspections, and client audits as a subject matter resource for facilities quality systems.

+ Identify compliance gaps and drive continuous improvement initiatives within the facilities quality function.

+ Support development, revision, and review of SOPs, work instructions, and quality documentation related to facilities and engineering processes.

Essential Skills

+ 3-7+ years of Quality Assurance experience in a GMP-regulated pharmaceutical, biotech, medical device, or related manufacturing environment.

+ Experience supporting facility, utility, equipment, engineering, or maintenance quality systems strongly preferred.

+ Demonstrated experience writing and managing Change Controls, CAPAs, and Investigations/Deviations.

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Experience with Blue Mountain software required or strongly preferred.

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Experience with equipment calibration, preventive maintenance programs, and asset management systems is highly desirable.

+ Prior experience working cross-functionally with Facilities, Engineering, Validation, and Manufacturing teams.

Additional

Skills & Qualifications

+ Bachelor's degree in Life Sciences, Engineering, Quality, or related technical discipline preferred.

+ Equivalent combination of education and relevant GMP experience may be considered.

Work Environment

The work environment involves a GMP-regulated manufacturing setting. The role requires collaboration with various teams, including Facilities, Engineering, Validation, Manufacturing, and Quality Control. Utilization of technologies such as Blue Mountain Regulatory Asset Manager is essential. Ensuring compliance with GMP regulations and maintaining inspection readiness are vital components of the role.

Job Type & Location

This is a Contract position based out of Philadelphia, PA.

Pay and Benefits

The pay range for this position is $36.05 - $40.87/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision
- Critical Illness, Accident, and Hospital  - 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…