QA Auditor III - GMP, Biologics , Analytical Chemistry , Quality

Submission for the position: QA Auditor III - GMP, Biologics , Analytical Chemistry , Quality - (Job Number: 183130)

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 customers through our collaborative approach, including PPD Laboratories FSP.

PPD Laboratories FSP is a unique partnership that allows our customers 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 a QA Auditor III, focus on Quality Assurance (QA) review and approval of technical documents pertaining to GMP analytical methods for biologics (large molecules) drug substances and drug products. The scope of documents will range from early clinical development through registration and commercial lifecycle of methods. Specific technical document types include analytical method procedures, method validation protocols and reports, method transfer protocols and reports, reference standard and critical reagent qualification protocols and reports, certificates of analysis, analytical change controls and general procedural documents. You will also partner with analytical functional areas to resolve associated deviations and other exceptional conditions, and assist with CAPA identification and resolution.

Additional responsibilities while work onsite at a major biopharmaceutical customer site:

Perform the QA review/approval of technical documentation, including but not limited to: Analytical method validation protocols and reports for in process, release, and stability testingAnalytical method procedures and associated change controlsMethod technical transfer protocols and reportsReference material and critical reagents qualification protocols and reportsStandard Operation Procedures and other controlled documentsCollaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations and exceptional conditions related to validation or technical transfer of analytical methods or qualification of reference material and critical reagentsCommunicate, share and escalate issues within team for consensus resolutionAssist in the development of procedural and other guidance documents for Quality and QC functions

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 well being of our employees.   

Join PPD in our relentless pursuit of excellence - apply now!

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 customers through our collaborative approach, including PPD Laboratories FSP.

PPD Laboratories FSP is a unique partnership that allows our customers 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 a QA Auditor III, focus on Quality Assurance (QA) review and approval of technical documents pertaining to GMP analytical methods for biologics (large molecules) drug substances and drug products. The scope of documents will range from early clinical development through registration and commercial lifecycle of methods. Specific technical document types include analytical method procedures, method validation protocols and reports, method transfer protocols and reports, reference standard and critical reagent qualification protocols and reports, certificates of analysis, analytical change controls and general procedural documents. You will also partner with analytical functional areas to resolve associated deviations and other exceptional conditions, and assist with CAPA identification and resolution.

Additional responsibilities while work onsite at a major biopharmaceutical customer site:

Perform the QA review/approval of technical documentation, including but not limited to: Analytical method validation protocols and reports for in process, release, and stability testingAnalytical method procedures and associated change controlsMethod technical transfer protocols and reportsReference material and critical reagents qualification protocols and reportsStandard Operation Procedures and other controlled documentsCollaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations and exceptional conditions related to validation or technical transfer of analytical methods or qualification of reference material and critical reagentsCommunicate, share and escalate issues within team for consensus resolutionAssist in the development of procedural and other guidance documents for Quality and QC functions

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 well being of our employees.   

Join PPD in our relentless pursuit of excellence - apply now!

Education and Experience:  

Bachelor's degree in life sciences or equivalent and relevant formal academic / vocational qualification Previous Biologics QA, QC, analytical chemistry, method development experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 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. Preferred Experience: Previous experience in QC laboratory facing QA activities is highly desirable (i.e. OOS, OOT, laboratory related deviations) Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity, PDLIMS, Trackwise) is desirable. Experience and/or knowledge of QC biologics testing Working knowledge of GMP environment is desirable

Knowledge, Skills and Abilities:      Working knowledge of QC, QA, analytical method development or method validation functions Meets competencies for QA Auditor I plus: Thorough knowledge of FDA guidelines, GxP regulations and appropriate regional research regulations and guidelines

Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management

Excellent oral and written communication skills

Strong attention to detail

Strong problem solving, risk assessment and impact analysis abilities

Solid experience in root cause analysis

Above average negotiation and conflict management skills

Flexible and able to multi-task and prioritize competing demands/workload  

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. 

keywords: "method development", "method validation", "quality control" , "quality assurance", QA, QC, "method transfer", "analytical chemistry", biologics, GMP

PPDFSP

*LI-NW1

Education and Experience:  

Bachelor's degree in life sciences or equivalent and relevant formal academic / vocational qualification Previous Biologics QA, QC, analytical chemistry, method development experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 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. Preferred Experience: Previous experience in QC laboratory facing QA activities is highly desirable (i.e. OOS, OOT, laboratory related deviations) Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity, PDLIMS, Trackwise) is desirable. Experience and/or knowledge of QC biologics testing Working knowledge of GMP environment is desirable

Knowledge, Skills and Abilities:      Working knowledge of QC, QA, analytical method development or method validation functions Meets competencies for QA Auditor I plus: Thorough knowledge of FDA guidelines, GxP regulations and appropriate regional research regulations and guidelines

Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management

Excellent oral and written communication skills

Strong attention to detail

Strong problem solving, risk assessment and impact analysis abilities

Solid experience in root cause analysis

Above average negotiation and conflict management skills

Flexible and able to multi-task and prioritize competing demands/workload  

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. 

keywords: "method development", "method validation", "quality control" , "quality assurance", QA, QC, "method transfer", "analytical chemistry", biologics, GMP

PPDFSP

*LI-NW1 Submission for the position: QA Auditor III - GMP, Biologics , Analytical Chemistry , Quality - (Job Number: 183130)