Investigations Lead - Parenteral Pharma QA & CAPA

Zohorecruit

Northern (KY)

On-site

USD 90,000 - 130,000

Full time

4 days ago

Be an early applicant

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

Zohorecruit is seeking an Investigation Lead to provide operational and scientific expertise, together with compliance knowledge, in support of manufacturing sterile and non-sterile operations. The resource will execute manufacturing investigations (Quality Events, or QEs) and facilitate the collection and coordination of information required to support those investigations.

Requirements include a Bachelor’s degree in Science, Pharmacy, and/or Engineering, five years in a parenteral

Qualifications

Bachelor's degree in Science, Pharmacy, or Engineering.
Five years in a parenteral manufacturing facility.
At least one year of experience in the investigation process.
Strong technical writing and presentation skills.
Ability to interpret and analyze statistical data.
Knowledge of cGMPs, OSHA, EPA and regulatory standards.
Proficiency with Word, Excel, and PowerPoint.
Excellent interpersonal and teamwork skills.
Bilingual in Spanish and English.

Responsibilities

Ensure QE, NTRs, and NOEs are completed and closed within the established timeframe.
Review and provide input to regulatory submissions for the area of responsibility.
Lead QE and CAPA trend evaluations.
Participate in regulatory inspections when necessary.
Support site initiatives and other assignments.