ADVANCE YOUR CAREER WHILE SAVING LIVES

Location: Oklahoma City, O

K
Pay: Competitive pay based on education and/or experience plus $500 bonus after 6 months and $1,000 bonus after 1 yea

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

tc.
Days: Monday through Friday; occasional week

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

p.m.
Pos

ition:
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.
Qualifi

• cations:
  Bachelor's degree in Biological or Biomedical science or E
• quivalent2 years of experience in product manufacturing o
• r R&D2 years of experience in Quality management and/or Quality
• AssuranceKnowledge of Master control or similar software for documen
• t controlFamiliarity with current cGMP standards is d
• esirable.Exposure to the regulatory landscape related to cell and gene therapy-related
• products.Excellent written and verbal communicatio
• n skills.Excellent knowledge of Microsoft Office, including Word, Excel Spreadsheet and Po
• werPoint.Ability to effectively communicate with the key stak

eholders.
Primary Respons

• ibilities:
  Create and implement verification plans for equipment and
• facilities.Create and implement process valida
• tion plans.In coordination with R&D staff, execute verification and valida
• tion plans.Identify the gaps in the current procedure and revise procedures and forms a
• s required.Develop and implement plans for transitioning Research Use Only (RUO) products and procedures to cGMP and cGT compli
• ant status.Create and implement cGMP batch records for newly develope
• d products.In collaboration with OBI quality management staff create and file DMF for newly develope
• d products.Train and educate R&D staff in cGMP, quality assurance and quality control methods and doc
• umentation.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 prope
• rty rights.Maintain QC records for supplies, reagents, and equipment used to manufacture and test newly develope
• d products.Maintain and review manufacturing and inve