Senior Data Processing Specialist â Chemistry (Data Processing)
Senior Data Processing Specialist â Chemistry (Data Processing)
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Job Description
Position Summary: Ensure the client receives quality data in a timely manner by processing laboratory 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 appropriate
- Demonstrate and promote the company vision
- Regular attendance and punctuality
- Data processing of 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 calculations
- Communication in writing and in person with laboratory personnel in an intelligent and clear manner
- Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
- Perform processing of scientific data including but not limited to standard preparation calibrations methodology QC sample data integrations compound evaluation chemical identification and other subjective review based on testing performed; perform complex calculations to verify results
- Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology
- May serve as technical advisor for analysts with regard to QA/QC of data
- Diagnose problems; solve simple problems and suggest solution to complete problems in professional area
- Keep 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 employees
- Use MS Windows applications such as Excel Word Access Outlook email; create complex Excel worksheets and formulas
- Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
- Conducts all activities in a safe and efficient manner
- Performs other duties as assigned
Qualifications :
Education/Experience (BMQ):
Masters degree in a science-related field with at least 7-10 years of experience in Bio/Pharmaceutical Chemistry drug product/substance testing with knowledge of regulatory requirements and data processing responsibilities
Experience with analytical techniques data processing such as pH meter XRD KF Chromatography Assay and impurity analysis (HPLC/UPLC GC ICetc.) knowledge of USP/EP compendia and laboratory software applications such as Waters Empower software 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
