Method Validation Documentation Specialist

Tris Pharma • Monmouth Junction, NJ

1d • Onsite

About The Position

Tris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on the development and commercialization of innovative medicines. The Method Validation (MV) Documentation Specialist supports the MV department by creating, revising, and organizing all new and revised specifications and associated test methods and documents. This role ensures compliance with the Management of Change (MOC) system, Standard Operating Procedures (SOPs), and current Good Manufacturing Practices (cGMPs). The incumbent is also responsible for the preparation, revision, and maintenance of other departmental documentation, including annual reports, SOPs, raw material qualification reports, risk assessment reports, release and stability specifications, and outside contract laboratory reports.

Requirements

• Bachelor’s degree in Chemistry or related science field and minimum 8 years’ experience in analytical development or MV in the pharmaceutical or biotechnology industry OR Master’s degree in Chemistry or related science field and minimum 5 years’ experience in analytical development or MV in the pharmaceutical or biotechnology industry
• Hands-on experience with multiple analytical instrumentation which may include: UV/IR, HPLC, LC-MS, GC, GC-MS, ICP-MS, TLC and dissolution apparatus
• Working knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidances
• Excellent recordkeeping ability
• Proficiency with Microsoft Office, including Excel
• Verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• Planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)
• Ability to identify and distinguish colors

Responsibilities

• Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws
• Creates all new and revised specifications and associated test methods and specifications in compliance with MOC system
• Prepares annual reports for commercial products and supports documents for submission
• Performs compendial review for Research and Development (R&D) projects
• Prepares and assembles raw material qualification reports for commercial products
• Supports documents for submission, residual solvent risk assessment, elemental impurity risk assessment reports, nitrosamine risk assessment reports for drug products
• Organizes and maintains an in-house archiving system for laboratory notebooks, logbooks, data packs, method validation reports and other appropriate scientific documentation
• Enters results in release and stability specifications
• Reviews and revises applicable SOPs, as needed
• Performs related duties, as assigned

Benefits

• bonus eligible
• medical insurance
• dental insurance
• vision insurance
• Rx insurance
• 401K with match
• life insurance
• paid Company Holidays
• PTO
• Paid Volunteer Time
• Employee Resource Groups

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 251-500 employees