QC Data Reviewer (Pharma)

QC REVIEWER - PHARMA

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, 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 QC Reviewer you will monitor the quality of laboratory data and reports.

At PPD 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: 

Monitors the quality of laboratory data and reports. Reviews chromatographic data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).

Essential Functions:  

Evaluates laboratory data for compliance with analytical methods and SOPs. Reviews sample results for completeness and accurate representation of the data and report findings. Communicates with laboratory staff to proactively address the quality of laboratory documentation. Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction. Trains new QC Reviewers and laboratory staff. Conducts SOP review and writing. Conducts consultations for quality records. Performs other duties as assigned.

QC REVIEWER - PHARMA

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, 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 QC Reviewer you will monitor the quality of laboratory data and reports.

At PPD 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: 

Monitors the quality of laboratory data and reports. Reviews chromatographic data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).

Essential Functions:  

Evaluates laboratory data for compliance with analytical methods and SOPs. Reviews sample results for completeness and accurate representation of the data and report findings. Communicates with laboratory staff to proactively address the quality of laboratory documentation. Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction. Trains new QC Reviewers and laboratory staff. Conducts SOP review and writing. Conducts consultations for quality records. Performs other duties as assigned.

Education and Experience:   Bachelor's degree or equivalent and relevant formal academic / vocational qualification Min. 2 years experience - laboratory analytical experience utilising chemistry analytical techniques and reviewing data. Experience in chromotography.

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 train staff 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

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.  

#LI-MH1

Education and Experience:   Bachelor's degree or equivalent and relevant formal academic / vocational qualification Min. 2 years experience - laboratory analytical experience utilising chemistry analytical techniques and reviewing data. Experience in chromotography.

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 train staff 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

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.  

#LI-MH1