Sr Associate QA
at Ronin Staffing

Date Posted: 11/17/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title: Sr Associate QA 
Pay: up to $30.00/hr
Location: Thousand Oaks, CA 91320
Duration: 2 year contract with possible extension

Description:

  • Onsite. Candidate must be able to work day shift or swing shift. Candidate must be flexible to allow for shift changes. Day(7-6) Swing(12-11)-Sun-Wed or Wed-Sat.
  • Ideal candidate- exp. in GMP environment within MFG or Bio-tech industry. Experience in review and approval of batch records, NC/CAPA's and Change Control records.
  • Bulk Quality Assurance provides quality and compliance oversight of the manufacturing plant for the Drug Substance Intermediate, Drug Substance, and Drug Product stages. This includes cell bank, cell culture, purification, and aseptic formulation/fill/finish processes. The position also provides quality oversight of plant support functions such as maintenance, metrology, engineering, and automation.

Responsibilities:

  • Provide Quality Assurance oversight for manufacturing and support operations for biopharmaceutical products.
  • Ensure compliance to GMP regulations for area operations and associated or support processes.
  • Support investigations/deviation reports (nonconformance reports).
  • Management of GMP documentation including real time manufacturing document review, approval, and archiving.
  • QA contact and approver for Class 1 Nonconformances.
  • Provide plant floor Quality oversight to maintain an inspection ready facility as part of 75% required time on the manufacturing floor.
  • May be asked to give additional assistance to management within the Quality Assurance group as needed. For example, metrics compilation or data gathering, project support, etc.

Preferred Qualifications:

  • Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field.
  • Demonstrated science based approach and an ability to deliver results.
  • Experience working in multiple GMP databases.
  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
  • Experience in review and approval of batch records, NC/CAPA's and Change Control records.
  • Demonstrated ability to use computer databases for query of data, managing status, and input of data and documentation.
  • Previous experience in Amgen’s quality systems (SAP, LIMS, Change Control (CCMS), Trackwise, EDMQ, Maximo).
  • Ability to focus on detail and ensure the accuracy of executed tasks and documentation per GMP standards.
  • Effective verbal and technical written communication skills.
  • Strong interpersonal skills to articulate quality requirements and rationale to others.
  • Knowledgeable of regulatory requirements/Quality Principles.
  • Able to effectively handle and operate in a rapidly changing environment.
  • Strong team player.
  • Complex decision making skills, ability to complete tasks autonomously, provide updates to area manager, and identify potential issues.
  • Experience performing batch record review and previous manufacturing experience.
  • 1+ years of experience.

Job Details:

  • Candidate must be able to work day shift or swing shift. Candidate must be flexible to allow for shift changes.

Top Must Have Skill Set:

  • Experience working in multiple GMP databases.
  • Experience in review and approval of batch records, NC/CAPA's and Change Control records.
  • Previous experience in Amgen’s quality systems (SAP, LIMS, Change Control (CCMS), Trackwise, EDMQ, Maximo).

Day to Day Responsibilities:

  • Provide QA oversight on manufacturing floor
  • Batch record review
  • Nonconformance/Deviation closures
  • Proved QA oversight during document revisions

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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