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Quality Assurance Validation Specialist (Engineer) Compliance (Biotech)

Lynkx Staffing

Quality Assurance Validation Specialist (Engineer) Compliance (Biotech)

Saddle Brook, NJ
Full Time
Paid
  • Responsibilities

    Our biotechnology client is seeking a QA Validation Specialist (Engineer), Compliance, reporting to the Associate Manager, Quality Compliance. The incumbent will be responsible for validating/qualifying equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures in support of Quality Systems. This role is responsible for reviewing, revising and approving qualification/validation protocols and reports (e.g. facilities, processes, and equipment). Collaborates cross-functionally to support required on-going compliance activities. Support continuous improvement activities and fostering of quality mindset.

    • Supporting validation activities in a cGMP regulated manufacturing environment: review and approve executed qualification and validation documents (IQ, OQ, PQ), for facilities, processes, and equipment.
    • Troubleshooting of process issues, process characterization and root cause investigations.
    • Resolving deviations observed during execution of qualification and validation activities.
    • Approve final reports summarizing the results of executed Validation, Qualification studies.
    • Prepare and issue change controls, CAPAs, and investigation reports after validation activities.
    • Participate in planning committee meetings to plan qualification and validation activities with key stakeholders ensuring quality requirements are enforced (e.g. Validation Production Operators, and Engineering).
    • Support all internal and external (e.g. cGMP, client, regulatory agencies) audits.
    • Engage in quality system continuous improvement initiatives to enforce the quality culture.
    • Other duties as assigned

    REQUIREMENTS

    • B.S. Engineering or related life science degree required. Electrical Engineering background preferred but not required.
    • 5 years+ experience in the pharmaceutical or related industry; equivalent combination of education and experience acceptable.
    • Familiar with FDA, ISO, and other regulatory agency guidelines.
    • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required. 
    • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPs etc.) required.
    • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc required.
    • Experience in clinical and commercial manufacturing preferred.
    • Experience supporting or participating in health authority inspections and/or client audits preferred.
    • Relevant computer skills (Microsoft Office, Outlook)
    • Detail-oriented and organized
    • Analytical and problem-solving skills
    • Good written and oral communication skills
    • Ability to multi-task and be adaptable
    • Flexible and able to adapt to company growth and evolving responsibilities
    • Ability to work independently and with a team
    • Strong Project Management and organization skills
    • Must be able adaptable, collaborative, accountable, and have a "can-do" pioneering spirit.
    • Must be able to work in a team-oriented environment.
    • Must be able to work occasional weekends, nights, and/or holidays as required/necessary.
    • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
    • Must be able to handle the standard moderate noise of the manufacturing facility.
    • Must be able to work in open floor plan environment and may work in close proximity to others.
    • Wheel-o-Vator available for use.
    • Must be able to utilize proper personal protective equipment (PPE) to handle human specimens, gases, corrosive chemicals, etc.
    • Able to utilize equipment in manufacturing are as well QC laboratories.
    • Understanding and comprehension of quality system applications.

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

     

     

     

     

     

     

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