Investigation Specialist-Quality

SUMMARY

The Investigation Specialist is responsible for driving the resolution of product quality related issues and complaints by gathering and analyzing relevant information, determining the accurate root cause and defining appropriate corrective/preventive actions to prevent recurrence meeting regulatory (FDA, DEA, Boards of Pharmacy) expectations. The specialist will ensure CAPA effectiveness and assist in leading QMS communication within the organization.

This is an on-site position in Ocala, FL.

Essential Functions and Responsibilities

• Perform investigations independently to assess aberrant events impacting product quality that could prevent product release. Perform interviews and schedule follow-up meetings in response to investigations.

• Perform gap assessments and root cause analysis evaluations to determine RISK level utilizing root cause analysis tools such as FMEA, fishbone, and/or 5 Why tools.

• Ensure root cause analyses, CAPA effectiveness checks and risk analysis for products, processes and systems

• Gather data and perform trending

• Recommend quality process improvements to increase efficiencies and performance of systems,

Education and Experience:

• 3 – 5 years of hands-on experience in Quality/Pharmaceutical environment preferred

• Bachelor’s degree preferred

• Proficiency in technical writing

• Experience with root cause analysis tools

• Demonstrated “change agent” skills; inclusive of influence management, project management, vision development, and people motivation skills.

• Effective written and verbal communication, interpersonal and organizational skills.

• Must be results-oriented, able to make decisions independently using critical thinking skills, and able to prioritize work per business needs

• Strong knowledge of GMPs and FDA, DEA, BoP regulatory requirements

Job Type: Full-time

Pay: From $24.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday
• Weekends as needed

Application Question(s):

• Do you havea Bachelors Degree (BA/BS) in Science (Chemistry, Microbiology or Biology) or Engineering, Quality Management or related field? –(Preferred)
• Do you have at least 3 to 5 years’ experience in Quality/Pharmaceutical environment? Required
• Do you have experience with root cause analysis/CAPAs? Required
• Do you have proficiency in technical writing? Required
• Do you have strong knowledge of GMPs and FDA, DEA, BoP regulatory requirements? Required

Ability to Relocate:

• Ocala, FL 34474: Relocate before starting work (Required)

Work Location: In person

Salary : $24