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Sr Scientist - QC Reviewer

Company: Pharmaceutical Product Development, LLC
Location: Richmond
Posted on: November 24, 2022

Job Description:

PPD clinical research services is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD clinical research services, we are passionate, deliberate, and driven by our purpose- to improve health!

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD - Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

As a Sr.Scientist - QC Reviewer, you will monitor the quality of laboratory data and reports.

At PPDclinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

  • Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and the industry.
  • Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols.
  • Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.
    Essential Functions:
    • Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems.
    • Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision.
    • Prepares study protocols, project status reports, final study reports and other project-related technical documents.
    • Communicates data and technical issues to the client and responds to client needs and questions.
    • Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.
    • Assists with quality systems and new equipment.
    • Assists in designing method validation or method transfer protocols and establish project timelines.
    • Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
    • Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. #GD #LI-AP1 #HP-CRGlabs Job Qualification Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
      Knowledge, Skills and Abilities: Solid understanding and knowledge of general chemistry and separation science Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff PPD clinical research services values the health and wellbeing 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.
      • As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment. Our 4i Values: Integrity - Innovation - Intensity - Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you! Diversity Statement PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group. --- All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.

        --- All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.

Keywords: Pharmaceutical Product Development, LLC, Richmond , Sr Scientist - QC Reviewer, Other , Richmond, California

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