About this role
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 appropriateDemonstrate and promote the company visionRegular attendance and punctualityRead and understand analytical proceduresReview documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPsGain a technical understanding of the techniques in which review is being performedUse MS Windows applications such as EXCEL, Word, Access, Outlook emailConducts all activities in a safe and efficient mannerPerforms other duties as assigned Basic Minimum Qualifications (BMQ):
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
Education/Experience (BMQ):
Master’s degree in a science-related field with 4-7 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.), knowledge of USP/EP compendia, 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 detailAbility to communicate effectively with coworkers and internal/external clientsAbility to learn new tasks quickly and to move easily from task to taskAbility to handle prioritization and multiple tasks simultaneouslyAbility to use a personal computer and learn necessary programsGood communication skills (oral and written)Organizational ability and good judgementScience background/education and/or laboratory experienceStrong Math SkillsLogical Thinking, Good Reasoning AbilityMotivation to excelCoaching/mentoring of peers