Quality Assurance Senior Associate

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.

The Senior Associate QA role supports client's Quality Assurance program, providing daily oversight of Drug Substance manufacturing facilities at client's Thousand Oaks, CA. facility. Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems.

Duties include purposeful presence on the manufacturing floor, batch record review, SOP and MP revision approval, work order approval, and quality approval of deviations and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment to ensure workplace safety.

This staff member will be assigned to provide quality support during either day or night shift schedule periods, as operation support is 24/7.

Top Must-Have Skill Sets:

• Technical writing experience (i.e. deviation records, CAPA records, controlled documents)
• Excellent verbal and written cross functional communication skills
• Must have biotech/pharma manufacturing, quality assurance, or quality control experience
• Biotech/ Pharma experience required
• Must be able to work swing, morning, evenings, night shift (24/7 Operation building). Once trained it will 4 day work week.

Day to Day Responsibilities:

• Purposeful presence on the manufacturing floor (80% of working time spent on MFG floor in controlled, classified cell culture and protein purification areas).
• Batch record review
• SOP and MP revision approval
• Work order approval
• Quality approval of deviations and CAPAs
• Safety auditing and observational work
• GEMBA walks

Red Flags:

• Not able to work onsite
• Unable to work shifts including morning, evening, or potentially nights
• No Biotech/ Pharma background/experience
• No quality assurance, quality control experience

Interview process: Phone screening followed by in-person interview.