Sr. Associate QA – Biopharma (JP5063)

Location: Thousand Oaks, CA
Date Posted: 12-03-2018
Job Title: Sr. Associate QA – Biopharma (JP5063)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Cell Bank, DS, and DP Floor QA
Duration: Initial 3 years
Rate: 24-28/Hr
3Key Consulting is looking for Sr. Associate QA for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.

Job Description:
First 2 months - Day shift 8-5 M/F
After 2 months - Sunday - Wednesday days or swings.

This role supports Amgen’s Quality Assurance program under the Manufacturing Floor QA organization providing daily oversight of Cell Bank, Cell Culture, Purification, Drug Product Formulation/Fill, and Small Molecules production activities. 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 electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of class 1 nonconformances 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.

Basic Qualifications:
Master's Degree OR
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:
  • Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field.
  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
  • Experience managing projects through to completion meeting timelines
  • Evaluating documentation and operations according to company procedures
  • Capable of making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk
  • Experience working with Quality Systems
  • Strong organizational skills and ability to manage multiple tasks at one time
  • Effective communication skills (both written and verbal)
  • Demonstrated ability to work as both a team player and independently

Top Must have Skill Sets:
  • Experience in GMP Enviorment familiarity with Non-conformance and CAPAs
  • Quality Systems (Trackwise experience preferred)
  • Schedule Flexibility
Day to Day Responsibilities:
  • Batch record review
  • Nonconformance CAPAs QA on document revisions
  • Purposeful presence on the floor

Employee Value Proposition:
This person would gain transferable skillets in this role. Nonconformance, CAPA's etc. Chance to be hired on in a full-time role.
Red Flags: PHD's, overqualified for position.

Interview Process: Phone screening followed by Panel interview
We invite qualified candidates to send your resume to  If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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