Specialist Product Quality
at Ronin Staffing

Date Posted: 1/4/2020

Job Description

HERE’S THE JOB DESCRIPTION:       
Title: Specialist Product Quality 
Pay Rate: DOE
Location: West Greenwich, RI 02817
Length: 3 year contract

Ideal candidate

  • B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
  • Experience working in a regulated environment (either direct GMP or technical support).
  • Strong project management skills

Description:

  • Onsite M-F
  • As a Specialist Stability you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management.
  • In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.
  • The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.

Key Responsibilities include:

  • Build and maintain technical GMP documents and product stability studies
  • Review, verify, report, and archive GMP data for clinical and commercial products
  • Apply keen attention to detail to conduct data review and reports
  • Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
  • Adeptly manage time-sensitive activities independently

Basic Qualifications

  • Doctorate degree, or
  • Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, or
  • Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience

Top Must Have Skill Set:

  • Experience working in a regulated environment (either direct GMP or technical support)
  • Strong project management skills
  • Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques

Day to Day Responsibilities:

  • The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections.
  • Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations.

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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