You'll be crucial in ensuring clients receive quality data by meticulously reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations.
Essential Duties and Responsibilities
- Apply GMP/GLP in all areas of responsibility, as appropriate.
- Demonstrate and promote the company vision.
- Ensure 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 for which review is being performed.
- Use MS Windows applications such as Excel, Word, Access, and Outlook email.
- Conduct all activities in a safe and efficient manner.
- Perform other duties as assigned.
Qualifications
- Education/Experience: Master's degree in a science-related field (Biochemistry / Biotechnology / Microbiology) with 3-7 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements.
- Experience with analytical techniques such as qPCR, microbiological techniques, knowledge of USP/EP/JP compendia, and laboratory software applications such as PCR analysis software, bioinformatics tools, and LIMS 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 judgment.
- Science background/education and/or laboratory experience.
- Strong Math Skills.
- Logical Thinking, Good Reasoning Ability.
- Motivation to excel.
- Coaching/mentoring of peers.
