Job Abstract

ADVANCE YOUR CAREER WHILE SAVING LIVES

Location: Oklahoma City, OK

Pay: Competitive pay based on education and/or experience plus $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; occasional weekends

Hours: 8:30 a.m. to 5:00 p.m.

Position:

The Quality Management Specialist will create and perform validations for processes, equipment, and facilities under the direction and guidance of the Director of R&D and in coordination with OBI quality management staff. The position will also assist in the creation, verification, and implementation of standard operating procedures (SOPs), and work instructions (WI). The position in collaboration with OBI quality management will design, develop and implement the creation of Drug Master Files (DMF) as needed.

Qualifications:

• Bachelor's degree in Biological or Biomedical science or Equivalent
• 2+ years of experience in product manufacturing or R&D
• 2+ years of experience in Quality management and/or Quality Assurance
• Knowledge of Master control or similar software for document control
• Familiarity with current cGMP standards is desirable.
• Exposure to the regulatory landscape related to cell and gene therapy-related products.
• Excellent written and verbal communication skills.
• Excellent knowledge of Microsoft Office, including Word, Excel Spreadsheet and PowerPoint.
• Ability to effectively communicate with the key stakeholders.

Primary Responsibilities:

• Create and implement verification plans for equipment and facilities.
• Create and implement process validation plans.
• In coordination with R&D staff, execute verification and validation plans.
• Identify the gaps in the current procedure and revise procedures and forms as required.
• Develop and implement plans for transitioning Research Use Only (RUO) products and procedures to cGMP and cGT compliant status.
• Create and implement cGMP batch records for newly developed products.
• In collaboration with OBI quality management staff create and file DMF for newly developed products.
• Train and educate R&D staff in cGMP, quality assurance and quality control methods and documentation.
• Assist R&D leadership in reviewing the validation studies, writing summaries, and getting approval from the OBI Quality department.
• Help create product history documents for intellectual property rights.
• Maintain QC records for supplies, reagents, and equipment used to manufacture and test newly developed products.
• Maintain and review manufacturing and inventory data.