What are the responsibilities and job description for the Quality Assurance Senior Associate - (JP10386) position at 3 Key Consulting?
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:
Basic Qualifications:
Preferred Qualifications:
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
Day to Day Responsibilities:
Red Flags:
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.
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.