Senior QC Reviewer - Data Review , GMP

Pharmaceutical Product Development (PPD)

MA-Cambridge-FSP Cambridge MA


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 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.

As aSr. QC Reviewer,you will will be responsible for ensuring and enforcing group compliance to all laboratory, documentation, procedural and regulatory requirements. You will also be responsible for supporting various analysts in QC documentation roles.

Additional responsibilities for the role on site at a major biopharmaceutical company:

Be part of a team of analysts who are responsible for all aspects of laboratory data review (technical and compliance), authoring laboratory investigations and certificates of analysis

Serve as the QC lead for data integrity projects

Assist in ensuring 100% inspection readiness

Develop, drive and maintain KPI’s and metrics for the QC lab

Responsible for trending OOS, OOT and invalids and implementing process improvements

Monitor and ensure timely closure of all laboratory investigations, OOS, OOT, invalids and CAPA’s

Monitor and ensure all deliverables for batch release and stability are met

Assist in driving process improvement projects for the QC lab and organization

Review investigations, specifications and other GMP documentationAt 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 team will review your qualifications and if interested, you will be contacted for an interview.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 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.

As aSr. QC Reviewer,you will will be responsible for ensuring and enforcing group compliance to all laboratory, documentation, procedural and regulatory requirements. You will also be responsible for supporting various analysts in QC documentation roles.

Additional responsibilities for the role on site at a major biopharmaceutical company:

Be part of a team of analysts who are responsible for all aspects of laboratory data review (technical and compliance), authoring laboratory investigations and certificates of analysis

Serve as the QC lead for data integrity projects

Assist in ensuring 100% inspection readiness

Develop, drive and maintain KPI’s and metrics for the QC lab

Responsible for trending OOS, OOT and invalids and implementing process improvements

Monitor and ensure timely closure of all laboratory investigations, OOS, OOT, invalids and CAPA’s

Monitor and ensure all deliverables for batch release and stability are met

Assist in driving process improvement projects for the QC lab and organization

Review investigations, specifications and other GMP documentationAt 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 team will review your qualifications and if interested, you will be contacted for an interview.

Education and Experience:

Bachelor's degree in the life or physical sciences with a preference for a concentration in microbiology, analytical chemistry or pharmaceutical chemistry, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experiencePreferred Experience:Experience with Waters Empower Software and TrackWise preferred

Previous experience working in a GMP laboratory requiredKnowledge, Skills, and Abilities:

Thorough knowledge of SOPs and Federal Regulations to include GLP, GDP, and GMP requiredThorough knowledge of chromatography and divisional SOPsStrong technical knowledge including an understanding of laboratory procedures, methodology and standardsWorking knowledge of MS Office programs (Outlook, Word, Excel, PowerPoint)Strong verbal and written communication skillsStrong organizational and presentation skillsStrong attention to detailAbility to independently review laboratory reports and analytical methodsAbility to deal with multiple and changing prioritiesAbility to provide clear and concise feedback and/or documentation of resultsAbility to work with minimal supervision as well as in a collaborative team environment

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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements, including infectious agents,typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesPPD 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 in the life or physical sciences with a preference for a concentration in microbiology, analytical chemistry or pharmaceutical chemistry, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experiencePreferred Experience:Experience with Waters Empower Software and TrackWise preferred

Previous experience working in a GMP laboratory requiredKnowledge, Skills, and Abilities:

Thorough knowledge of SOPs and Federal Regulations to include GLP, GDP, and GMP requiredThorough knowledge of chromatography and divisional SOPsStrong technical knowledge including an understanding of laboratory procedures, methodology and standardsWorking knowledge of MS Office programs (Outlook, Word, Excel, PowerPoint)Strong verbal and written communication skillsStrong organizational and presentation skillsStrong attention to detailAbility to independently review laboratory reports and analytical methodsAbility to deal with multiple and changing prioritiesAbility to provide clear and concise feedback and/or documentation of resultsAbility to work with minimal supervision as well as in a collaborative team environment

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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements, including infectious agents,typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesPPD 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. 


2020-10-23 00:00:00


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