PPD Scientist / Senior Scientist - GMP , Sample Management , Reference Standards in Boston, Massachusetts
In labs and health care facilities worldwide - HERE WE ARE
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 Scientist/Senior Scientist, you will join the client Release and Stability QC Laboratory team supporting a variety of GMP functions that occur. You will provide day-to-day support of Reference Standard and Release and Stability.
Additional responsibilities for the role on site at a major pharmaceutical company: * Manage the day-to-day support for the Reference Standard program * Author Certificate of Analysis (COA) and ensure timely certification of more than 100 standards * Handles reference standards for all clients at the client's facility and maintains the database for all analytical reference standards * Ensures that all reference standards are current and that expired reference standards are removed from service * Maintain accurate, well-kept notebooks for the reference standard Certificate of Analysis (COA) * Maintains inventory for all reference standards and ensures that each are labeled appropriately. * Maintains electronic copies of all reference standard Certificate of Analysis (COA) * Perform Stability pulls and deliver samples to various departments * Coordinate and stationing of samples for qualification testing * Maintain stability chambers and remove terminated stability samples * Manage sample receipt of incoming material and timely shipment of samples to external labs * Compile and summarize analytical raw data in various report formats * Reviews various laboratory documentation such as equipment usage logbooks and daily check log books * May perform review and verification of data generated for release, raw materials, stability and cleaning verification activities * May author and review analytical reports and certificates of analysis * Participate in generation of metrics reports and identify areas for process improvements * Contributes to laboratory clean-up activities and overall inspection readiness * May participate in regulatory agency audits and inspections * May participate in and author OOS/OOT investigations, planned deviations and change controls * Maintains individual training compliance at 100% * Follows protocols and SOPs to perform job functions * Performs other duties as assigned
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!
_What To Expect Next_
We look forward to receiving your application. A member of our talent acquisition department will review your qualifications and if interested, you will be contacted for an interview.
Education and Experience: * Bachelor's degree in the life or physical sciences with a preference for a concentration 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 2 year) or equivalent combination of education, training, & experience.). * Experience with LIMS or data management systems strongly preferred * GMP experience strongly preferred Knowledge, Skills and Abilities: * Knowledge of applicable regulatory authority, compendia and ICH guidelines * Knowledge of pharmaceutical analytical testing techniques and equipment- HPLC, GC, Dissolution, KF * Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use * Demonstrate strong attention to detail organizations skills * Ability to utilize Microsoft Excel and Word to perform tasks * Ability to independently optimize analytical methods * Good written and oral communication skills * Time management and project management skills * Problem solving and troubleshooting abilities * Ability to work in a collaborative work environment with a team *Working Environment: *
/PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:/
* Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. * Able to work upright and stationary and/or standing for typical working hours. * Able to lift and move objects up to 25 pounds * Able to work in non-traditional work environments. * Able to use and learn standard office equipment and technology with proficiency. * May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. * Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. *PPD Defining Principles: *
We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
Key words: "sample management" , "GMP", "HPLC" , "reference standards" , "sample coordinator"
Organization: *US BU
Title: Scientist / Senior Scientist - GMP , Sample Management , Reference Standards
Location: MA-Boston-FSP Boston MA
Requisition ID: 201969
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group
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