Specialist Manufacturing
at Ronin Staffing

Date Posted: 11/5/2019

Job Description

HERE’S THE JOB DESCRIPTION:
Title
: Specialist Manufacturing 
Pay: DOE
Location: Thousand Oaks, CA 91320
Duration: 1 year contract + possible extension

Job Description:

  • On-site
  • Ideal Candidate- Previous Amgen experience. Preferably experience in a quality role. Seasoned self-starter, excellent communication and interpersonal skills. This individual will be coordinating team projects, making sure hitting milestones and on track with project plan. This person will also be managing Supplier change notifications and owning/executing change control process.
  • Minimum Qualifications - Bio pharma experience or background sector with solid Project Management and Quality Management skills and experience.
  • The Specialist is expected to own deviations, CAPA, CAPA-EV, supplier investigations (SICAR & EN), Change Control and have metrics oversight responsibilities. Experience with managing multiple records is important and TrackWise user knowledge is an advantage.
  • May act as the External Supply Lead driving consistency across all Specialists in the space.
  • Will be required to communicate with many functions within the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.
  • May serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites.

Basic Qualifications:

  • Master’s degree and 4 years of Quality and/or Manufacturing experience
  • OR
  • Bachelor’s degree and 6 years of Quality and/or Manufacturing experience
  • OR
  • Associate’s degree and 8 years of Quality and/or Manufacturing experience
  • OR
  • High school diploma / GED and 10 years Quality and/or Manufacturing experience

Preferred Qualifications:

  • 6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
  • Thorough understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
  • Thorough working knowledge of owning deviations, CAPAs, CAPA-EVs and change controls
  • Demonstrated ability to work autonomously, present data in an organized and logical manner, and communicate effectively
  • Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
  • Excellent interpersonal relationship skills.
  • Excellent oral and written communication skills.
  • Proficient with Trackwise; MSWord; MS Excel; MS PowerPoint
  • Ability to maintain remote working relationships with colleagues at other Amgen sites.

Top Must Have Skill Sets:

  • Project Management of multiple projects concurrently, must be detailed oriented and organized self-starter
  • 5 years’ Experience in Pharma Industry, Supply Chain or Quality Experience preferred.
  • Quality Management and Quality Records ownership, must be detailed oriented and organized self-starter
  • Proficient to expert skill with PowerPoint (Management Updates and Presentations), Excel spreadsheets (use of formulas, perform analysis and calculations efficiently)

Day to Day Responsibilities:

  • Receive training for quality record management activities
  • Take over Project Management of existing project and create new project plans as needed, Schedule and facilitate project team meetings and manage project task tracker and dashboards updating.
  • Own Quality Records such as Supplier Change Notifications and Change Controls

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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