Data Review Specialist â Pharmaceutical Microbiology
Data Review Specialist â Pharmaceutical Microbiology
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Job Description
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
Qualifications :
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):
Masters degree in Microbiology field with 3-6 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements.
Theoretical / Practical experience with analytical techniques such as environmental monitoring Gel clot endotoxins growth promotion kinetic endotoxin MLT organism identification and particulate matter testing. Knowledge of USP/EP compendia and LIMS Electronic Notebook is preferred.
Additional Information :
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
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
