Senior Quality Assurance Analyst

2 weeks ago


Waltham, Massachusetts, United States Pace Life Sciences Full time
About Us

Pace Life Sciences

Pace is dedicated to enhancing global health and safety. We support the pharmaceutical and biopharmaceutical sectors through the entire drug development lifecycle, from initial research and development to clinical trials and commercial product support. For clients with internal manufacturing and laboratory facilities, we offer professional services tailored to their operational needs.

Job Overview

The individual in this role will be accountable for the analysis, management, and supervision of extensive chemistry and biochemistry policies, programs, and practices. This position may involve providing expert feedback and guidance to clients regarding the evaluation of materials, products, and devices, utilizing specialized knowledge in chemistry, biochemistry, formulation development, and related methodologies.

Key Responsibilities
  • Lead and mentor team members, providing direction and training.
  • Oversee the completion and processing of various forms, documents, and databases.
  • Conduct specialized analyses to support testing of materials and products using advanced analytical instrumentation, adhering to established Standard Operating Procedures.
  • Review and interpret testing results, analyzing complex operations and presenting findings and recommendations to management and clients.
  • Provide training on analytical methods and instrumentation as necessary.
  • Advise clients and staff on chemistry and biochemistry policies and practices, facilitating broad operational changes.
  • Assist in the development of project objectives, including budgets and timelines, and communicate progress to management.
  • Develop, validate, and transfer analytical methods, performing routine and specialized analyses using instruments such as HPLC, GC, LC-MS, and FTIR.
  • Design and create scalable formulations for small molecules and biologics for early-stage clinical trials, optimizing manufacturing processes.
  • Ensure compliance with SOPs, regulatory guidelines, and GLP/GMP standards.
  • Contribute to departmental efficiency by actively participating in team initiatives and offering constructive suggestions.
  • Support Pace Analytical's mission by fostering a cooperative and positive workplace environment.
Qualifications
Education and Experience
  • Bachelor's degree in chemistry, biochemistry, or a closely related discipline.
  • Three to five years of relevant experience, including specialized technical operations; a Master's or PhD is preferred.
Required Knowledge and Skills
  • In-depth understanding of chemistry and biochemistry principles and formulation development techniques.
  • Familiarity with the administration of chemistry and biochemistry programs and policies.
  • Ability to resolve complex chemistry-related issues.
  • Knowledge of applicable laws and regulations in the field.
  • Proficiency in analytical tools and equipment.
  • Strong communication skills for effective collaboration with team members and clients.
Additional Information

Benefits

Pace Life Sciences offers a comprehensive benefits package, including paid vacation, holidays, sick leave, medical, dental, and vision insurance, retirement plans, and various voluntary insurance options.

Equal Opportunity Employer

Pace Life Sciences is committed to providing equal employment opportunities and prohibits discrimination of any kind.



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