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Specialist Product Quality

GPS Staffing West Greenwich, RI
  • Posted: 11 days ago
  • Other
GPS Staffing is a nationwide preferred provider of staffing and recruitment services. GPS has over 25 years of dedicated staffing partnerships with organizations ranging from International Fortune 500 companies to Colorado startups. Our team is committed to Growth, People and Success!

Title: Product Quality Specialist
Job ID: 6836
Industry: Biotech/Pharmaceutical
Location: West Greenwich, RI
Duration: 3-Year Contract
Pay Rate: Depends on Experience (Hourly W2)

Job Details:
  • 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.
Key Responsibilities:
  • 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
  • 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.
  • Company offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines.
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
Top Must Have Skills:
  • 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
Education Required:
  • 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


Note to Applicants:
We will not respond to everyone personally - qualified candidates will be contacted for a screening.
Please submit your resume in a Word document.

GPS Staffing

Address

West Greenwich, RI
02817 USA

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