Quality Assurance Senior Associate JP

Quality Assurance Senior Associate

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

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  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  You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.