QA Engineer

Job Description

QA Engineer

Location: Tampa, FL
Industry: Pharmaceutical
Hours: 8am-5pm M-F, on-site 100%
Salary: Up to $40.00/hr. depending on experience
Employment Type:
Up to one year contract depending on business needs and performance

Environment:
This client is one of the world s leading suppliers to the pharmaceutical, biotech, and specialty ingredients markets. We create products that support a healthier lifestyle and enhance one s quality of life.
Overview:
The QA Engineer is responsible for ensuring the timely development, review and approval of all engineering, validation and lifecycle documentation, (i.e. SOPs, Change Controls, CAPAs, Deviations), ensuring compliance with corporate procedures, SOPs, cGMP, standards and implementing industry best practices.
Key Accountabilities:

• Responsible for the Quality review and approval of engineering and validation documentation to support requirements Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ); validation master plans, risk assessments, calibration and periodic reviews, etc.
• Participate with plant & external engineering resources on new installations & systems to ensure that factory, site, & commissioning documentation is in accordance with current Good Manufacturing Practices ( cGMP ) & supports validation.
• Support all aspects of the Validation Life Cycle from design through operation and improvements, and the revalidation program.
• Represent QA in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation)
• Create, review, and approve SOPs, Change Control and Corrective Action Preventive Action (CAPA) and additional documentation and quality systems such as SOPs, forms, reports, deviation, etc. as needed.
• Works directly with operating entities, with multiple functions, internal and external, to provide Quality validation support to assure requirements meet project expectation and meet local procedures and regulations.
• Interface with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC departments to resolve process issues and implement changes.
• Identify, analyze, and manage risk through product life cycle with use of risk management tools.
• Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
• Participate in internal, client and/or regulatory audits.
• Work with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
• Establish, maintain, trend and report Quality KPI and metrics.
• Participate in Management Review, Quality Review Board Deviation Review Board and Change Review Board as required.
• Other tasks as assigned by Senior Manager of QA Operations.

Requirements:

• Minimum high school diploma, BS degree preferred in relevant field
• Minimum of 3-5 years Pharmaceutical or related FDA industry experience required doing similiar responsibilities

ADA/EOE
IND
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SRG4 Life Sciences delivers flexible staffing solutions nationwide, specializing in pharmaceutical, CDMO/CMO, medical device, clinical research, PBM, pharmacy, food and beverage, nutraceutical, laboratory, and consumer product sectors. We provide contract, contract-to-hire, and direct hire placements across a wide range of critical roles including Scientists, Formulators, Engineers, QA/Regulatory Affairs, Microbiologists, Manufacturing Technicians, Supply Chain/Procurement Specialists, Project Managers, and Business Development professionals. SRG4 Life Sciences operates on a relationship-driven model partnering closely with clients to understand not only the role, but the company s culture, goals, and vision.

Our mission is to match purpose-driven professionals with organizations committed to advancing human health, building long-term partnerships that drive innovation, quality, and performance.