Associate Scientist Quality Technical Services

Quality Bronx, New York


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

Job Purpose: Provides technical support to assigned projects, using robust scientific methods which comply with standard operating procedures and scientific standards. Works with limited direction. As appropriate, may serve as a project leader to manage analytical support for projects with supervision.

Major Duties / Responsibilities

% of Time

1.       With minimal supervision, create/update and document new/revised product specifications and test methods which are robust and meet regulatory requirements.

10

2.       Successfully investigate and resolve moderately-complex analytical problems, project issues and deviations. Accurately maintain all related documentation in compliance with SOPs.

15

 

3.       Research, prepare and review technical documents, including but not limited to SOPs, drug master files, technical packages, vendor qualification, USP verification raw material and release and stability specifications, test methods, and certificates of analysis which conform to company standards.

15

4.       Attend and present data at project-related meetings, interact with other departments and outside testing laboratories to ensure proper analytical testing.

5

5.       Participate in cross-functional project teams, and exercise and build basic team effectiveness skills.

5

6.       Utilize skills, established procedures, new methodologies, and experience to complete tasks; and provide formal and informal mentoring to interns and Technicians.

10

7.       Develop, validate and transfer of complex and non-complex analytical methods.

40

Knowledge, Experience and Education:

  • Demonstrated proficiency in the use of a variety of standard analytical instruments, such as UPLC, HPLC, GC, Headspace-GC, Dissolution, UV-Vis and FTIR.
  • Extensive knowledge of a variety of compendial references, including USP or European Pharmacopeia.
  • The ability to develop, document and execute analyses or experiments of moderate complexity, ensuring methods are robust and reliable.
  • The ability to maintain high quality research documentation, analyze and interpret data.
  • Experience in designing and drafting method validation, transfer, verification, conversion and equivalency protocols and reports
  • Experience in writing technical reports including Compendial method verifications, elemental impurity, vendor qualification and residual solvent statements
  • Must be able to work independently on multiple concurrent projects, and communicate effectively with interdisciplinary project teams.
  • These skills are normally acquired through completion of a bachelor degree in Chemistry or Pharmaceutical Sciences combined with 3 to 5 years of relevant experience in a cGMP or cGLP laboratory.

 Principle Challenges:

  • Typical Problems: Provides successful resolution of complex analytical problems, deviation investigations, and method improvements. Uses established procedures to perform assigned tasks directly related to the functional assignments. 
  • Most Complex Problems: The initial development and continual evaluation of analytical test methods and specifications throughout the development of new products and revised formulations represents complex challenges.   Ensuring that all laboratory documentation is maintained accurately and completely and staying abreast of multiple, moderately-complex technologies; and maintaining focus while involved in multiple, concurrent projects present complex challenges.
Decision Making Authority:
  • What typical decisions does the job have total authority for making? Reviews notebook and raw documentation for all testing. Approval of the following analytical documentation: Method Validation Protocols, Method Validation Reports, Planned test method adjustments, Analytical Reports, Method Validation Deviations, OOS/Atypical Investigation Forms, COAs, Sample receipt logbooks, Test Method, Specifications, SOPs, BPPs, USP Action Plans, Equipment EQ, Equipment DQ, and Impact Assessments.
  • What typical decisions are referred to others for approval? Review of the following analytical documentation is referred to higher levels: Equipment EQ. Unplanned changes in project scope and complex issues that may present significant risk and/or impact to the business may be escalated. Uses professional judgment as to what issues are escalated to Management.
  • Additional Information: List any information not included in the previous answers that is important to know about the position. The average duration of a project assigned at this level is 6 months. The average number of projects that a scientist at this level would lead over one year is 5-8. A scientist at this level would write and review method validation protocols and reports, method transfer reports, and analytical reports with minimal guidance.