QC Specialist - Lab Quality

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.

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:

Ensures the quality of laboratory data and reports. Reviews analytical 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). Performs non-routine and complex analytical data reviews ensuring scientific soundness and method validation. Provides expertise to the laboratory and quality groups in one or more specialized areas such as chromatography, microbiology, method validation or other applicable areas.

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness. Validates large and/or non-routine projects. Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness. Determines whether laboratory staff effectively validated a particular method.

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

Provides expert knowledge in one or more analytical techniques to assist laboratory and quality groups make informed decisions.

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.

Assists the departmental manager or supervisor in the evaluation of the laboratory QC program. Helps maintain compliance and assists in continuous improvement of laboratory processes.

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!

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.

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:

Ensures the quality of laboratory data and reports. Reviews analytical 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). Performs non-routine and complex analytical data reviews ensuring scientific soundness and method validation. Provides expertise to the laboratory and quality groups in one or more specialized areas such as chromatography, microbiology, method validation or other applicable areas.

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness. Validates large and/or non-routine projects. Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness. Determines whether laboratory staff effectively validated a particular method.

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

Provides expert knowledge in one or more analytical techniques to assist laboratory and quality groups make informed decisions.

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.

Assists the departmental manager or supervisor in the evaluation of the laboratory QC program. Helps maintain compliance and assists in continuous improvement of laboratory processes.

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

Knowledge, Skills and Abilities:

Expert knowledge of SOPs and Federal Regulations to include GLP and GMP

Expert knowledge of chromatography or other applicable analytical techniques 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 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

Management Role:

No management responsibility

Working Environment:

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 game changers - 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 5 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

Expert knowledge of SOPs and Federal Regulations to include GLP and GMP

Expert knowledge of chromatography or other applicable analytical techniques 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 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

Management Role:

No management responsibility

Working Environment:

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 game changers - 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.