QC Reviewer - Small Molecule

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.

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.

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: 

As a QC Reviewer you will monitor the quality of laboratory data and reports.

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.

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.

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.

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: 

As a QC Reviewer you will monitor the quality of laboratory data and reports.

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

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities: Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP Thorough knowledge of small molecule, HPLC, and Empower required Experience with batch release, stability, and validation preferredThorough 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

Working Environment:  

P PD 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.  

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.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities: Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP Thorough knowledge of small molecule, HPLC, and Empower required Experience with batch release, stability, and validation preferredThorough 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

Working Environment:  

P PD 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.