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QC Reviewer- Vaccine Lab

Pharmaceutical Product Development (PPD)

CN-Suzhou-Suzhou CN YongAn Road

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform.

This is a great time to join PPD China. Currently PPD is recruiting for a QC Reviewer, monitors the quality of vaccine laboratory data and reports, reviews 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

l Evaluates vaccine laboratory data for compliance with analytical methods and SOPs.

l Reviews sample results for completeness and accurate representation of the data and report findings.

l Communicates with laboratory staff to proactively address the quality of laboratory documentation.

l Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction.

l Trains new QC Reviewers and laboratory staff.

l Conducts SOP review and writing. Conducts consultations for quality records.

l Performs other duties as assigned.

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform.

This is a great time to join PPD China. Currently PPD is recruiting for a QC Reviewer, monitors the quality of vaccine laboratory data and reports, reviews 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

l Evaluates vaccine laboratory data for compliance with analytical methods and SOPs.

l Reviews sample results for completeness and accurate representation of the data and report findings.

l Communicates with laboratory staff to proactively address the quality of laboratory documentation.

l Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction.

l Trains new QC Reviewers and laboratory staff.

l Conducts SOP review and writing. Conducts consultations for quality records.

l Performs other duties as assigned.

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 2 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP Bacis knowledge of vaccine and pathogenic microorganism

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 Fluent in English, CET-4 is a must.     

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.  

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 2 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP Bacis knowledge of vaccine and pathogenic microorganism

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 Fluent in English, CET-4 is a must.     

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.  

Job posted: 2020-10-21

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