Stability Coordinator in Rensselaer, NY

Date Posted: 06/26/2020

Job Snapshot

  • Employee Type:
    Full-time
  • Location:
    Rensselaer, NY
  • Job Type:
    Quality
  • Experience:
    Individual Contributor
  • Date Posted:
    06/26/2020

Job Description

Description

Stability Coordinator in Rensselaer, NY AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.  The Stability Coordinator is an integral part of the AMRI team, contributing to our success by providing technical, organizational and compliance support for ongoing and prospective stability studies. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.  In this role, you will:
• Review of analytical data and documentation for compliance with cGMPs, AMRI SOPs and other written procedures.  Primarily chromatographic data, but also instrumental testing such as DSC, XRPD, water analysis, USP testing, etc.  Identification of deviations.  Trending of stability data to ensure consistency with historical timepoints and no unexpected results.
• Managing timelines and multiple projects: Interface with scientists and management to coordinate testing timelines, corrections to documentation, and reporting within defined turnaround times.  Adjusting priorities based on due dates and invoicing goals.
• Writing stability protocols.
• Interfacing between sites (Albany and Rensselaer) to coordinate testing for efficiency and use of site-exclusive equipment.
• Direct, technical communication with customers (primarily, external).  Reporting results, technical discussion, addressing questions.
• Formatting and review of reports: Stability Summary tables; accuracy and compliance with current AMRI formats.
• Managing invoicing for stability: request of POs for contract laboratories, issuing BRFs, working with finance to ensure accurate and complete accounting for stability projects, review of monthly invoices.  Tracking monthly and quarterly financial projections.
• Controlled substances handling includingmaintaining inventory, paperwork, biannual review.
• Manage quality investigations (e.g., deviations) as necessary.
• Manage workload and time to enable the incumbent to perform multiple projects effectively, and ensure all necessary paperwork is completed on a timely basis.
• Volunteer to assist with other tasks in the analytical function not directly related to specific projects.
• Participate in self-development activities and training of others.
• Perform other related duties as may be reasonably assigned in the course of business.
• Future: writing proposals and designing studies for stability.
• The Stability Coordinator is encouraged to display a degree of professionalism reflected in part by increasing the scientist's knowledge of theory and practice through reading scientific journals and texts at times beyond the "normal" working hours.

Qualifications

Qualifications and background to be successful in this role:  Required
• Bachelor’s degree in a relevant field with major in Biology, Chemistry, Natural Science or Pharmacy or equivalent required with minimum of 2+ years of previous professional experience
• Good knowledge of analytical chemistry including wet chemistry and instrumental methods of analysis.
• Strong computer and math skills.
• Demonstrated written & verbal skills
• Technical troubleshooting skills
• Critical thinking & problem solving skills such as DMAIC
• Analytical data review Preferred
• Experience with ERP, LIMS and document control systems preferred  PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; sit; and use hands to finger, handle, or feel.  The employee frequently is required to reach with hands and arms and talk or hear.  The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.  Incumbent may be required to obtain/qualify for and maintain the clearance to wear a respirator at a “class B” level or above following OSHA mandated guidelines.  WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles and toxic or caustic chemicals.  The employee is frequently exposed to wet and/or humid conditions.  The employee is occasionally exposed to moving mechanical parts and risk of electrical shock.  The noise level in the work environment is usually moderate. All interested applicants must apply online.  AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job: Quality
Primary Location: Rensselaer, New York
Schedule: Full-time
Job Posting: 06/26/2020
Shift Type:

AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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