Senior Scientist - Data Reviewer - Empower - GMP
**Boston, Massachusetts, United States** at
Feb 15, 2019Post Date
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**EXPECT MORE FROM YOUR CAREER**
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
As a **Senior Scientist-Data Reviewer** , you will provide data review and reporting for release, stability, cleaning verification, raw material, method qualification and method transfer testing activities supporting the Client's Manufacturing Center's Release and Stability Laboratory (RSL).This position is a non-lab based position.
Additional responsibilities for the role on site at a major pharmaceutical company:
+ Review and reporting of instrument qualification data in a cGMP environment.
+ Perform cGMP analytical data review for various techniques such as HPLC, GC, KF, TOC, IR and dissolution.
+ Compile and summarize analytical raw data in various physical and electronic report formats.
+ Review laboratory equipment logbooks and daily check logbooks.
+ Data entry and various administrative functions for laboratory data systems.
+ Maintain cGMP training compliance.
+ May coordinate and track progress of analytical testing internally or at CROs.
+ May participate in regulatory agency audits and inspections.
+ May author and review protocols, analytical reports and certificates of analysis.
Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you chose to Be with PPD.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.
Join PPD in our relentless pursuit of excellence - apply now!
Education and Experience:
+ Bachelor's degree in life or physical sciences with a preference in Chemistry, Analytical Chemistry, or Pharmaceutical Chemistry or equivalent and relevant formal academic / vocational qualification
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years') or equivalent combination of education, training, & experience. OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ year)
+ 2-years of experience in quality doing review
+ Experience with Waters Empower chromatography software, SLIM data management system, IDBS Electronic Lab Notebook (ELN), and/or Trackwise is preferred.
Knowledge, Skills and Abilities:
+ Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
+ Thorough knowledge of chromatography and divisional SOPs
+ Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
+ Strong verbal and written communication skills
+ Strong attention to detail
+ Ability to independently review laboratory reports and analytical methods
+ Ability to deal with multiple and changing priorities
+ Ability to provide clear and concise feedback and/or documentation of results
+ Ability to work in a collaborative team environment
+ Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
+ Knowledge of HPLC, GC, KF, TOC, and dissolution
+ Ability to utilize Microsoft Excel and Word to perform tasks
+ Time management and project management skills
+ Problem solving and troubleshooting abilities
+ Work is performed in an office environment with exposure to electrical office equipment.
+ May have exposure to laboratory and/or a clinical environment
+ Exposure to biological fluids with potential exposure to infectious organisms.
+ Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
+ Personal protective equipment required such as protective eyewear, garments and gloves.
+ Exposure to fluctuating and/or extreme temperatures on rare occasions.
+ Ability to work in an upright and /or stationary position for 6-8 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
+ Occasional mobility needed.
+ Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
+ Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
+ Frequently interacts with others to obtain or relate information to diverse groups.
+ Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
+ Regular and consistent attendance.
+ **Requisition ID: 153939**
Associated topics: aseptic, biomedical, biopharmaceutical, cytometry, immunohematology, injury, medicine, nutrition, pharmacometrics, transfection