About this role
Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains
Essential Duties and Responsibilities:
Applies GMP/GLP in all areas of responsibility, as appropriateDemonstrate and promote the company visionRegular attendance and punctualityReview simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculationsCommunication in writing and in person with laboratory personnel in an intelligent and clear mannerExercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review processPerform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, chemical identification, and other subjective review based on testing performed; perform complex calculations to verify resultsVerify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodologyMay serve as technical advisor for analysts with regard to QA/QC of dataDiagnose problems; solve simple problems, and suggest solution to complete problems in professional areaKeep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employeesUse MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulasCommunicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concernsConducts 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 at least 7-10 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements and some data review responsibilities
Experience with analytical techniques data review such as pH meter, KF, Osmolality, protein concentration (via UV-Vis and SoloVPE). Advanced tests include plate reader assays, HPLC (SEC, AAA, peptide mapping, etc.), Capillary Electrophoresis, and Isoelectric Focusing. 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