Stability Scientist - Nebraska, United States - Innova Solutions

    Innova Solutions
    Innova Solutions Nebraska, United States

    2 weeks ago

    Innova Solutions background
    Contract
    Description

    Innova Solutions is immediately hiring for a Stability Scientist

    Tittle - Stability Scientist

    Duration: 12 months Contract
    Location: New Brunswick ,NJ (onsite)

    Pay Range*: $79.47- $81.17per hour.

    As a(n) Stability Scientist you will:

    Job Description:

  • The Principal Scientist stability is accountable for the stability program on assigned brand (s) and acts as Stability Product Lead.
  • Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements. Develops stability data where gaps exist.
  • Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products' performance/stability profile
  • Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change
  • Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations
  • Provide the technical requirements in a Master Stability Protocol, review and approve study specific protocols and /or batch enrollment forms
  • Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups.
  • Authors stability sections of CTD dossiers for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability related responses to health authority inquiries.
  • Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.
  • Leads work activities involving Change Controls and CAPA's .
  • Identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly, escalate promptly to management and act as required.
  • Responsible for stability procedures and ensures consistency with site department and groups procedures.
  • Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs
  • Support health authorities inspection internal and external.
  • Represents department in cross functional projects
  • Ensure training requirements are met.
  • Acts as an advisor and mentor to stability staff

    • The ideal candidate will have:

  • Required B.S. Chemistry, Biology, Microbiology or relevant discipline
    environment.
  • 8 years of relevant work experience required, preferable in a Pharmaceutical
  • Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C)
    and associated policies, directives and guidance documents. A thoroughknowledge of cGMP regulations as referenced in The Code of
  • Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
    Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods.
  • Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.

    • Thank you

    Aritra Roy

    PAY RANGE AND BENEFITS:

    Pay Range*: $79.47- $81.17per hour.

    *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

    Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).