Position Summary:
Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations
Essential Duties and Responsibilities:
Applies GMP/GLP in all areas of responsibility, as appropriate
Demonstrate and promote the company vision
Regular attendance and punctuality
Read and understand analytical procedures
Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs
Gain a technical understanding of the techniques in which review is being performed
Use MS Windows applications such as EXCEL, Word, Access, Outlook email
Conducts all activities in a safe and efficient manner
Performs other duties as assigned
Education/Experience (BMQ):
Master’s degree in a science-related field with 7-10 years of experience in Pharmaceutical Chemistry drug product/substance testing with knowledge of regulatory requirements.
Theoretical / Practical experience with analytical techniques such as pH meter, Spectroscopy (UV, IR,), Chromatography (HPLC/UPLC, GC, IC…etc.), Analytical method validations data review, knowledge of USP/EP compendia, ICH guidance, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred.
Key Candidate Attributes:
Self-motivation; excellent quality of work and attention to detail
Ability to communicate effectively with coworkers and internal/external clients
Ability to learn new tasks quickly and to move easily from task to task
Ability to handle prioritization and multiple tasks simultaneously
Ability to use a personal computer and learn necessary programs
Good communication skills (oral and written)
Organizational ability and good judgement
Science background/education and/or laboratory experience
Strong Math Skills
Logical Thinking, Good Reasoning Ability
Motivation to excel
Coaching/mentoring of peers
