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PPD Associate Systems Specialist - GMP Data Reviewer - Analytical Development 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 anAssociate Systems Specialist/QC Data Reviewer/Technical Writer, you will support the Analytical Development team at the client site by reviewing analytical data and writing technical reports, protocols, guidelines to support the cGMP and CMC regulatory submissions. This position is a non-lab-based position. Additional responsibilities for the role on site at a major pharmaceutical company: * Perform cGMP and development analytical data verification for analytical techniques that include: HPLC, GC, KF, IR, XRPD and PSD. * Compile and summarize analytical data in various physical and electronic report formats. * Review laboratory equipment logbooks for adherence to SOPs. * Track progress of analytical testing internally or at CMOs and summarize results, as appropriate. * Verify analytical sections for regulatory submissions. * Author technical reports to summarize studies, release, and stability data. * Maintain cGMP training compliance 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 Chemistry, Analytical Chemistry, Pharmaceutical Chemistry or equivalent and relevant formal academic / vocational qualification * Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 1 year) or equivalent combination of education, training, and experience.) with preferred 1-2 years’ experience in QC/data review. Knowledge, Skills and Abilities: * Knowledge of applicable regulatory authority, compendia and ICH guidelines * Knowledge of Analytical techniques such as: HPLC, GC, IR, XRD, PSD, and KF * Solid understanding and knowledge of general chemistry and separation science * Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use * Technical knowledge and understanding of laboratory procedures, methodology and standards * Ability to independently review laboratory reports and analytical methods * Ability to utilize Microsoft Suite, Excel and Word to perform tasks with SharePoint, Empower, and Kiteworks a plus * Ability to provide clear and concise feedback and/or documentation of results * Ability to write clear and concise technical documents * Ability to independently optimize analytical methods * Strong written and oral communication skills * Time management and project management skills * Ability to work in a collaborative work environment with a team * Able to demonstrate being detail oriented and able to deal with multiple and changing priorities 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. keywords: "analytical chemistry", "technical writer", "data review" , "GMP", "ICH", "USP", "HPLC" , "quality control" , "QC" LI-NW1 Job: Labs *Organization: US BU *Title: *Associate Systems Specialist - GMP Data Reviewer - Analytical Development Location: MA-Boston-FSP Boston MA Requisition ID: 188391

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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