Sr Associate QA
at Ronin Staffing

Date Posted: 8/25/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title
: Sr Associate QA 
Pay: up to $30.00/hr
Location: Thousand Oaks, CA 91320
Duration: 33 month contract with possible extension

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 Set:

  • Experience in GMP Environment 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

Job Snapshot

About Us

Founded in 1999 as a woman- and minority-owned IT staffing organization, Ronin Staffing has grown into a full-service staffing search firm that recruits and places qualified and quality candidates with expertise in a wide range of areas, including Engineering, Aerospace, Administration, Accounting/Financing, to name a few. We offer contract-only, contract-to-hire or direct-hire services to our clients and our contractors alike.

Our team of experienced, dynamic and tenacious recruiting specialists will provide you with the personal assistance you need to keep your career moving onward and upward. Whether you are looking for hourly, mid-management or executive level positions, you can be confident in our recruiters’ ability to match you with just the right assignments with just the right companies to suit your needs. Many members of our staff have backgrounds in the industries for which they now recruit, and Ronin has become one of the leaders in providing professionals to Fortune 100, 500, and 1000 companies.

We are proud to offer you a full line of services to help you to meet your career objectives, including resume assistance, human resources consulting, and expert guidance on professional interviewing techniques. We also offer direct deposit and a competitive benefits package.

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