Apply to Quality Assurance Senior Associate - (JP10386)

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.