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QUALITY ASSURANCE VALIDATION SPECIALIST

QUALITY ASSURANCE VALIDATION SPECIALIST

Oklahoma Blood InstituteOklahoma City, OK, US
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Job Description

Job Description

START YOUR CAREER WHILE SAVING LIVES

Location : Oklahoma City, OK

Salary : Competitive salary based on education and / or experience and $500 bonus after 6 months and $1,000 bonus after 1 year!

Benefits : Health, dental, vision, life insurance, long term disability, 401(k), paid-time off, $5,000 annual tuition reimbursement, holiday pay, etc.

Days : Monday through Friday

Hours : 8 : 00 a.m. to 5 : 00 p.m.

Position :

This position ensures all validations and verification approaches are current with regulatory requirements and are consistent with intended use. This role requires meticulous attention to detail, strong leadership, and provides technical guidance for all aspects of validation design and testing in a clinical laboratory setting.

Qualifications :

  • MT / MLS(ASCP) or MLT(ASCP) preferred
  • Bachelor's degree (B.S.) in related science field.
  • Minimum 2 years of Quality / Validation experience in regulated industry.
  • Strong understanding of clinical laboratory procedures and techniques
  • Understanding of FDA regulations, AABB standards, FACT standards, and cGMP / cGTP practices.
  • Strong problem-solving and strategic thinking skills, with the ability to adapt to unexpected challenges.
  • Ability to prioritize and perform under tight timelines.
  • Ability to work on multiple projects simultaneously, with strong attention to detail.
  • Ability to learn new processes and equipment independently.
  • Excellent written and verbal communication skills.

Primary Responsibilities :

  • Ensure validation approaches are current with regulatory expectations and standards, e.g., FDA CFR and Guidance's, CLIA, AABB, and FACT.
  • Provide technical expertise on instrument, equipment, and software validation design.
  • Ensure Process validations for new or changed processes are consistent with intended manufacturing and testing procedures.
  • Conduct reviews of validation documentation such as plans, test cases, data, and acceptance criteria.
  • Assist in writing validation summaries.
  • Ensure timelines are met and align with project implementations.
  • Assess change controls and risk assessments to ensure validated state of all GMP equipment and systems.
  • Serves as Validations resource for internal departments and vendors.

    • Job Posted by ApplicantPro

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    Quality Assurance Specialist • Oklahoma City, OK, US