QC Reviewer / Senior QC Reviewer - LIMS , GMP

Pharmaceutical Product Development (PPD)

CA-Foster City-FSP Foster City CA


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 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 a QC Reviewer/Sr.QC Reviewer, you will ensure and monitor the quality of laboratory data and reports, provide document coordination, and maintain GxP compliance.

Additional responsibilities for the role on site at a major biopharmaceutical company:Review 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).Performs non-routine and complex analytical data reviews ensuring scientific soundness and method validation.***This position is 100% desk work

Grow your career and chose to Be with PPD.

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.

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 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 a QC Reviewer/Sr.QC Reviewer, you will ensure and monitor the quality of laboratory data and reports, provide document coordination, and maintain GxP compliance.

Additional responsibilities for the role on site at a major biopharmaceutical company:Review 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).Performs non-routine and complex analytical data reviews ensuring scientific soundness and method validation.***This position is 100% desk work

Grow your career and chose to Be with PPD.

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.

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

Qualifications

Education and Experience:Bachelor's degree 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, & experience1-2 years of QA/QC experience preferredPrevious HPLC experience preferredKnowledge, Skills, and Abilities:Thoroughknowledge of SOPs and Federal Regulations to include GLP and GMPThorough knowledge of chromatography and divisional SOPsStrong technical knowledge including an understanding of laboratory procedures, methodology and standardsStrong verbal and written communication skillsStrong attention to detailAbility to train staffAbility 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 in a collaborative team 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 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 activitieskey words: HPLC, "data entry", LIMS, "data review"

*LI-NW1

Qualifications

Education and Experience:Bachelor's degree 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, & experience1-2 years of QA/QC experience preferredPrevious HPLC experience preferredKnowledge, Skills, and Abilities:Thoroughknowledge of SOPs and Federal Regulations to include GLP and GMPThorough knowledge of chromatography and divisional SOPsStrong technical knowledge including an understanding of laboratory procedures, methodology and standardsStrong verbal and written communication skillsStrong attention to detailAbility to train staffAbility 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 in a collaborative team 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 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 activitieskey words: HPLC, "data entry", LIMS, "data review"

*LI-NW1


2020-08-03 00:00:00


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