QUALITY ASSURANCE VALIDATION SPECIALIST at Oklahoma Blood Institute
Oklahoma City, OK 73104, USA -
Full Time


Start Date

Immediate

Expiry Date

04 Dec, 25

Salary

500.0

Posted On

04 Sep, 25

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Communication Skills, Regulated Industry, Thinking Skills

Industry

Information Technology/IT

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.

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.
  • 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.

How To Apply:

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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.
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