Boston Metro Area, Massachusetts
The Quality Control Scientist I (Quality Control Technical Services), under minimal supervision, is responsible for support of method development, qualification, validation, method transfer, and investigations in a cGMP environment. The Scientist works independently on assays that he/she has mastered or been assigned. The candidate must be able to work on projects with little supervision, write and execute method validation and special studies, and have oversight of a project. Experience with Empower software is preferred. Experience concerning cGMP, 21CFR, USP, EP, and ICH regulations. At least one year in a cGMP/GLP laboratory; quality control experience is preferred. Proficient in Windows, Microsoft Word, and Excel. Good written, verbal, and communication skills. Strong documentation skills
Perform biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
Work independently on assays that he/she has mastered.
Evaluate data against defined criteria/specifications.
Assist in the revision of written procedures as assigned.
Participate in coordination of completion of specific project tasks with other departments.
Develop, revise and author complex, explicit documentation, i.e. new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.
Participate in determining objectives of assignment.
Participate in the design and execute analytical method development, and qualification and validation.
Solve assay/analytically-related process problems.
Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process.
May manage analytical projects within the department.
Contribute to the understanding and interpretation of results and how they impact the design of subsequent experiments.
Contribute to development of project strategy in consultation with supervisor and/or colleagues.
Train and manage analysts and scientists as necessary.
Work independently with minimal supervision and direction.Proactive project management experience including multi-tasking of deliverables with competing timelines
Flexibility to adapt to changing priorities and delays
Fluency in ICH and GVP guidelines regarding periodic safety report content
Comfortable leading cross-functional meetings in English
Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment
Proficiency in Microsoft applications (Word, Power Point, Excel)
PharmD with a minimum of 3 years of clinical or industry experience and 2 years minimum of Pharmacovigilance experience. Or BA/BS with a minimum of 4 years of industry experience and 2 years minimum of Pharmacovigilance experience.