Senior Specialist - Analytical Data Processor - LC-MS Extractables and Leachable
Senior Specialist - Analytical Data Processor - LC-MS Extractables and Leachable
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Job Description
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 appropriate
Demonstrate and promote the company vision
Regular attendance and punctuality
Processing of simple and complex routine and nonroutine 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 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 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
Attention to details
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 pharma / sciencerelated field with at least 810 years of experience or Ph. D degree (preferred) with 5 years in Bio/Pharmaceutical Analysis experience with knowledge of regulatory requirements and data review responsibilities
Experience with chromatography and mass spectrometry analytical techniques (HPLC GC LC/MS GC/MS)
Experience identifying unknown compounds by mass spectrometry (ideally by LC/MSTOF and/or LC/MSQTOF)
Additional Preferences:
Experience with Agilent MassHunter software
Experience with extractables and leachables testing
Knowledge of USP/EP compendia and laboratory software applications such as Waters Empower software LIMS Electronic Notebook is preferred
Additional Information :
Key Candidate Attributes:
- Selfmotivation; 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 :
Fulltime
Employment Type
Full-time
