Quality Assurance Senior Associate
at Ronin Staffing

Date Posted: 11/3/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title
: Quality Assurance Senior Associate 
Pay: DOE
Location: Thousand Oaks, CA 91320
Duration: 18 month contract + possible extension

***SHIFT HOURS***IMPORTANT

  • This position will begin with regular M-F 8-5 hours then once the worker is fully trained (approx..2-3 months) there may be a chance they are moved to a shift with any of these possible shift times: 8am-5pm, 6am-3pm 12pm-10pm. So if your candidate has many obligations outside of work or specific scheduling requests and they are not flexible and willing to work ANY of the above shifts, then they will NOT be a good candidate for this role. They must be able to take on any of the above shifts

Description:

  • Ideal candidate- 2-3 years’ experience in Biotech industry either from manufacturing or quality.
  • Under minimal supervision, the Senior Associate Plant Quality Assurance is primarily responsible for performing quality review of documentation to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. Duties focus on providing quality guidance during on-the-floor manufacturing activities.

Responsibilities:

  • Author/review quality documents, such as: SOPs and Batch Records (electronic and paper-based)
  • Execute daily operations per management guidance in a dynamic environment.
  • Perform On-The-Floor (OTF) quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents.
  • Perform daily OTF inspections to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
  • Provide guidance during on-the-floor manufacturing and testing.
  • Support audits, inspections and investigations.
  • Adhere to LEAN practices and contribute to culture of continuous improvement.

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:

  • Strong cGMP and GDP behaviors
  • Demonstrated experience with deviations and CAPA records
  • Previous experience supporting GMP facilities.
  • Knowledge of electronic systems including LIMS, Trackwise, and Maximo
  • Strong organizational skills and ability to manage multiple tasks at one time
  • Ability to follow assignments through to completion and meet timelines
  • Exposure to regulatory agency inspectors or participation in regulatory agency audits.
  • Strong technical communication skills, both written and oral
  • Demonstrated ability to work as a team player and independently

Top Must Have Skill Set:

  • Previous GMP in biopharmaceutical
  • Previous quality experience
  • Able work different shifts

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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