Senior QC Reviewer

Pharmaceutical Product Development (PPD)

VA-Richmond-Richmond VA Dabney Rd


Title: Senior QC Reviewer

Division / Dept.: Immunochemistry

Location: Richmond, VA (Office Based)

Note: Full time, Benefits, Relocation Assistance Available

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. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

As an Sr. QC Reviewer, you will be an emerging scientific leader that is passionate about science, coaching and engaging analysts and overseeing laboratory operations on a daily basis.

PPD offers continued career advancement as an Sr. QC Reviewer, as well as management and specialized opportunities in other departments within 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.

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

The Sr. QC Reviewer monitors the quality of laboratory data and reports. Reviews Immunochemistry 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.

Responsibilities:

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness.Validates large and/or non-routine projects. Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundnessReviews sample results for completeness and accurate representation of the data and reports findingsCommunicates with laboratory staff to proactively address the quality of laboratory documentationPrepares 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 staffConducts SOP review and writing. Conducts consultations for quality recordsAssists the departmental manager or supervisor in the evaluation of the laboratory QC programPerforms other duties as assignedVideo links:

BioA Overview:

https://www.ppd.com/our-solutions/ppd-laboratories/bioanalytical-lab/

LinkedIn Video Landing Page:

https://www.linkedin.com/showcase/ppd-laboratories/?feedView=videos

Title: Senior QC Reviewer

Division / Dept.: Immunochemistry

Location: Richmond, VA (Office Based)

Note: Full time, Benefits, Relocation Assistance Available

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. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

As an Sr. QC Reviewer, you will be an emerging scientific leader that is passionate about science, coaching and engaging analysts and overseeing laboratory operations on a daily basis.

PPD offers continued career advancement as an Sr. QC Reviewer, as well as management and specialized opportunities in other departments within 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.

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

The Sr. QC Reviewer monitors the quality of laboratory data and reports. Reviews Immunochemistry 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.

Responsibilities:

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness.Validates large and/or non-routine projects. Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundnessReviews sample results for completeness and accurate representation of the data and reports findingsCommunicates with laboratory staff to proactively address the quality of laboratory documentationPrepares 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 staffConducts SOP review and writing. Conducts consultations for quality recordsAssists the departmental manager or supervisor in the evaluation of the laboratory QC programPerforms other duties as assignedVideo links:

BioA Overview:

https://www.ppd.com/our-solutions/ppd-laboratories/bioanalytical-lab/

LinkedIn Video Landing Page:

https://www.linkedin.com/showcase/ppd-laboratories/?feedView=videos

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, & experience

Knowledge, Skills, and Abilities:

Thorough knowledge of SOPs and Federal Regulations to include GLP and GMPThorough knowledge of Immunochemistry 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 Benefits Overview:

PPD offers comprehensive benefits including medical, dental, vision, pharmacy, employee assistance program, wellness program options and more.

Other benefits include:

401k with matching contributions, life insurance, long term and short term disability insurance, flexible medical and dependent care spending accounts.Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday and vacation sell back program.Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.Education reimbursement and tuition assistance programs, professional development training, skills training, education loan repayment plan, dependent scholarship program and more.Employee appreciation events, service recognition awards, annual reviews, merit plans and bonus plansCommunity connections and activities including philanthropic engagement, volunteer service projects and moreOther great options including pet insurance, legal and financial services plan, auto and home insurance discounts.

Below Is Listed The Working Environment/requirements For This Role

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. 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

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, & experience

Knowledge, Skills, and Abilities:

Thorough knowledge of SOPs and Federal Regulations to include GLP and GMPThorough knowledge of Immunochemistry 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 Benefits Overview:

PPD offers comprehensive benefits including medical, dental, vision, pharmacy, employee assistance program, wellness program options and more.

Other benefits include:

401k with matching contributions, life insurance, long term and short term disability insurance, flexible medical and dependent care spending accounts.Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday and vacation sell back program.Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.Education reimbursement and tuition assistance programs, professional development training, skills training, education loan repayment plan, dependent scholarship program and more.Employee appreciation events, service recognition awards, annual reviews, merit plans and bonus plansCommunity connections and activities including philanthropic engagement, volunteer service projects and moreOther great options including pet insurance, legal and financial services plan, auto and home insurance discounts.

Below Is Listed The Working Environment/requirements For This Role

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. 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


2020-07-06 00:00:00


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