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QC Specialist - Large Molecule Biopharm

Pharmaceutical Product Development (PPD)

PA-King of Prussia-FSP King of Prussia PA

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.

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.

The QC Specialist 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.

Responsibilities:

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness. Validates large and/ornon-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.

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!

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.

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.

The QC Specialist 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.

Responsibilities:

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness. Validates large and/ornon-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.

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!

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

Knowledge, Skills, and Abilities:

Thorough knowledge of SOPs and Federal Regulations to include GLP and GMPAt least one year of industry experience in a cGMP LabExperience with Large Molecule Biopharm HPLC, and/or ELISAExperience with cIEF is desiredThorough 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 environmentPPD 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 typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesRegular and consistent attendance

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

Knowledge, Skills, and Abilities:

Thorough knowledge of SOPs and Federal Regulations to include GLP and GMPAt least one year of industry experience in a cGMP LabExperience with Large Molecule Biopharm HPLC, and/or ELISAExperience with cIEF is desiredThorough 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 environmentPPD 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 typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesRegular and consistent attendance

Job posted: 2020-05-28

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