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 customers through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our customers 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 Data Reviewer/QC Reviewer, you will provide data review and reporting for release, stability, cleaning verification, raw material, method qualification and method transfer testing activities supporting the Customer'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
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.
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.
- 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 2 years’) or equivalent combination of education, training, & experience.
- 2 years of Data Review/QC Reviewer experience required
- Experience with Waters Empower chromatography software, SLIM data management system, IDBS Electronic Lab Notebook (ELN), and/or Trackwise is preferred.
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Knowledge of HPLC, GC, Dissolution, TOC, and KF preferred
- Knowledge of chromatography, divisional SOPs and FDA regulations.
- One year of QC experience; lab experience preferred.
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
- Ability to independently review laboratory reports and analytical methods
- 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
- Ability to utilize Microsoft Excel and Word to perform tasks
- Time management and project management skills
- Problem solving and troubleshooting abilities
- Good verbal and written communication skills.
- Must be detail oriented and able to deal with multiple and changing priorities.
PPD 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.
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.