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Associate Lead Quality Investigator - Technical Writing, Small Molecule, GMP

Pharmaceutical Product Development (PPD)

CA-South San Francisco-FSP San Francisco CA

Submission for the position: Associate Lead Quality Investigator - Technical Writing, Small Molecule, GMP - (Job Number: 172592)In labs and health care facilities worldwide - HERE WE AREPPD 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 anAssociate Lead Quality Investigator, you will provide support onsite at a major biopharmaceutical customer's new, state-of-the-art high containment drug product manufacturing facility in Small Molecule Pharmaceutical Sciences (SMPS), Research and Early Development (gRED). SMPS is responsible for the early pharmaceutical development (Ph I and II) of gRED small molecule drug candidates. You willbe heavily involved in maintaining compliant operation of the Building GMP Manufacturing Area. This includes (but is not exclusive to) the following activities:

Responsibilities:

Works closely with Senior Engineer to ensure that the SMPG Building GMP Manufacturing Area remains in a state of quality compliance.

Manages and completes discrepancy or investigation records in Trackwise with oversight and input from Senior Engineer and QA organization.

Drafts and reviews technical documents as required by ongoing projects, such as technical reports, standard operating procedures, qualification and validation protocols.

Executes and manages Change Records in Trackwise with oversight and input from Senior Engineer, QA organization, and other stakeholders as relevant.

Collaborates with SMPG Engineers as appropriate to advance ongoing projects from a Quality Engineering perspective, with oversight from Senior Engineer.

Support audit and audit response activities

At 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.

To learn how PPD can advance your career, apply now!

What To Expect Next

We are looking forward to receiving your application. A member of our talent acquisition team will review your application and if interested, you will be contacted for an interview.In labs and health care facilities worldwide - HERE WE AREPPD 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 anAssociate Lead Quality Investigator, you will provide support onsite at a major biopharmaceutical customer's new, state-of-the-art high containment drug product manufacturing facility in Small Molecule Pharmaceutical Sciences (SMPS), Research and Early Development (gRED). SMPS is responsible for the early pharmaceutical development (Ph I and II) of gRED small molecule drug candidates. You willbe heavily involved in maintaining compliant operation of the Building GMP Manufacturing Area. This includes (but is not exclusive to) the following activities:

Responsibilities:

Works closely with Senior Engineer to ensure that the SMPG Building GMP Manufacturing Area remains in a state of quality compliance.

Manages and completes discrepancy or investigation records in Trackwise with oversight and input from Senior Engineer and QA organization.

Drafts and reviews technical documents as required by ongoing projects, such as technical reports, standard operating procedures, qualification and validation protocols.

Executes and manages Change Records in Trackwise with oversight and input from Senior Engineer, QA organization, and other stakeholders as relevant.

Collaborates with SMPG Engineers as appropriate to advance ongoing projects from a Quality Engineering perspective, with oversight from Senior Engineer.

Support audit and audit response activities

At 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.

To learn how PPD can advance your career, apply now!

What To Expect Next

We are looking forward to receiving your application. A member of our talent acquisition team will review your application and if interested, you will be contacted for an interview.

Qualifications

Education and Experience:

Bachelor's degree in Life Sciences, Engineering, or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 0 - 2 years pharmaceutical manufacturing industry) or equivalent combination of education, training, & experience.

Preferred Experience:

Experience working in a GMP/GDP environment

Experience with solid oral dose manufacturing

Experience creating and executing technical documents and protocols for a GMP small molecule manufacturing environmentKnowledge, Skills and Abilities:

Experience working in a GMP/GDP environment required

Strong written and verbal communication skills

Knowledge of MS Office, Trackwise QMS system (related to investigations and change controls),

Knowledge of CONDOR document management system is a plus

Demonstrate strong technical writing skills

Strong technical knowledge including an understanding of laboratory procedures, methodology and standards

Strong attention to detail

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 environmentWorking Environment:

PPD values the health and well-being 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"manufacturing operations" , "technical operations" , "quality engineer" , compliance, "technical writing"

*LI-NW1

Qualifications

Education and Experience:

Bachelor's degree in Life Sciences, Engineering, or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 0 - 2 years pharmaceutical manufacturing industry) or equivalent combination of education, training, & experience.

Preferred Experience:

Experience working in a GMP/GDP environment

Experience with solid oral dose manufacturing

Experience creating and executing technical documents and protocols for a GMP small molecule manufacturing environmentKnowledge, Skills and Abilities:

Experience working in a GMP/GDP environment required

Strong written and verbal communication skills

Knowledge of MS Office, Trackwise QMS system (related to investigations and change controls),

Knowledge of CONDOR document management system is a plus

Demonstrate strong technical writing skills

Strong technical knowledge including an understanding of laboratory procedures, methodology and standards

Strong attention to detail

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 environmentWorking Environment:

PPD values the health and well-being 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"manufacturing operations" , "technical operations" , "quality engineer" , compliance, "technical writing"

*LI-NW1Submission for the position: Associate Lead Quality Investigator - Technical Writing, Small Molecule, GMP - (Job Number: 172592)

Job posted: 2020-07-17

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