Quality Assurance Senior Associate - (JP10386)
Company: 3 Key Consulting
Location: Louisville
Posted on: April 1, 2026
|
|
|
Job Description:
Job Title: Quality Assurance Senior Associate - (JP10386)
Location: Louisville, KY. 40201 Employment Type: Contract Business
Unit: International and Distribution Quality Duration: 2 years
(with likely extensions) Notes: Only qualified candidates, please.
Posting Date: 06/02/22 3 Key Consulting is hiring a Quality
Assurance Senior Associate for a consulting engagement with our
direct client, a leading global biopharmaceutical company. Job
Description: Perform receipt, manufacturing, storage, distribution,
and Facilities & Engineering documentation review to ensure
alignment with procedures, current Good Manufacturing Practices
(cGMP), Good Distribution Practices (GDP) and other applicable
regulations Perform cGMP process, procedure, document and record
review, approval and tracking, including but not limited to
Deviations, CAPAs, Change Controls, and Validations. May also
support execution of these tasks. Perform routine Quality Assurance
assessments of site operations and provide direct oversight.
Support Labeling and Packaging Operations including incoming raw
material inspection and manufacturing oversight. Represent the
Quality Unit during audits and inspections as needed. Support
internal/external audits and inspections as part of the
audit/inspection team as needed. Perform additional duties as
specified by management Basic Qualifications: Master’s degree and 1
year of Quality experience Bachelor’s degree and 2 years of Quality
experience OR Associate’s degree and 6 years of Quality experience
OR High school diploma / GED and 8 years of Quality experience
Preferred Qualifications: Ability to interpret and apply cGMP and
GDP Quality Assurance or manufacturing experience in the
pharmaceutical or medical device industry Good written and oral
communication Why is the Position Open? Supplement additional
workload on team. Top Must-Have Skill Sets: Self starter Attention
to detail Good written and oral communication Regulated environment
experience/ understanding of regulations Day to Day
Responsibilities: Perform receipt, manufacturing, storage,
distribution, and Facilities & Engineering documentation review to
ensure alignment with procedures, current Good Manufacturing
Practices (cGMP), Good Distribution Practices (GDP) and other
applicable regulations Perform cGMP process, procedure, document
and record review, approval and tracking, including but not limited
to Deviations, CAPAs, Change Controls, and Validations. May also
support execution of these tasks. Perform routine Quality Assurance
assessments of site operations and provide direct oversight.
Support Labeling and Packaging Operations including incoming raw
material inspection and manufacturing oversight. Represent the
Quality Unit during audits and inspections as needed. Support
internal/external audits and inspections as part of the
audit/inspection team as needed. Perform additional duties as
specified by management Red Flags: Inconsistent work history
Candidate should have regulated environment experience/
understanding of regulations Interview process: Phone screening
followed by in-person interview. We invite qualified candidates to
send your resume to resumes@3keyconsulting.com . If you decide that
you’re not interested in pursuing this particular position, please
feel free to take a look at the other positions on our website
www.3keyconsulting.com/careers. You are also welcome to share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Covington , Quality Assurance Senior Associate - (JP10386), Science, Research & Development , Louisville, Kentucky
