20 Quality Assurance Senior Associate - (JP10386) Jobs in Louisville, KY
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Quality Assurance Senior Associate - (JP10386)
$69k-86k (estimate)
Full Time | Business Services
6 Months Ago
3 Key Consulting is Hiring a Quality Assurance Senior Associate - (JP10386) Near Louisville, KY
Job Title: Quality Assurance Senior Associate - (JP10386)Location: Louisville, KY. 40201Employment Type: ContractBusiness Unit: International and Distribution QualityDuration: 2 years (with likely extensions)Notes: Only qualified candidates, please.Posting Date: 06/02/223 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:
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.
- 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
- 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
- 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
- Self starter
- Attention to detail
- Good written and oral communication
- ** Regulated environment experience/ understanding of regulations **
- 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
- Inconsistent work history
- Candidate should have regulated environment experience/ understanding of regulations
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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$69k-86k (estimate)
POST DATE
12/13/2023
EXPIRATION DATE
07/08/2024
WEBSITE
3keyconsulting.com
HEADQUARTERS
WEST HILLS, CA
SIZE
100 - 200
FOUNDED
2009
TYPE
Private
REVENUE
$50M - $200M
INDUSTRY
Business Services
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