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QA Specialist

Pharmaceutical Product Development (PPD)

KY-Highland Heights-Highland Heights KY Tessenee

Title: QA Specialist

Division / Dept.: Quality

Location: Highland Heights, KY (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.

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!

Summarized Purpose: Provides expertise to the department in one or more specialized areas, such as root cause analysis, corrective action/preventive action, batch record review, specialized laboratory testing, Total Quality Management (TQM), or other specialized areas/processes in the execution of the Quality Management System (QMS), which may include the performance of internal and/or vendor audits, participation in client or regulatory audits, required documentation review/approval, tracking of investigations, deviations or audit responses, the management of corrective and preventive (CAPA) action plans that result, and attendance at inter-departmental meetings related to the area of expertise. May serve as a QA client contact for company contracted services and contribute to policy-making decisions as a resource in area(s) of expertise.

PPD Richmond Labs Overview:

LinkedIn Video Landing Page:

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

#GD

#LI-JC1

PPDLABS

Title: QA Specialist

Division / Dept.: Quality

Location: Highland Heights, KY (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.

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!

Summarized Purpose: Provides expertise to the department in one or more specialized areas, such as root cause analysis, corrective action/preventive action, batch record review, specialized laboratory testing, Total Quality Management (TQM), or other specialized areas/processes in the execution of the Quality Management System (QMS), which may include the performance of internal and/or vendor audits, participation in client or regulatory audits, required documentation review/approval, tracking of investigations, deviations or audit responses, the management of corrective and preventive (CAPA) action plans that result, and attendance at inter-departmental meetings related to the area of expertise. May serve as a QA client contact for company contracted services and contribute to policy-making decisions as a resource in area(s) of expertise.

PPD Richmond Labs Overview:

LinkedIn Video Landing Page:

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

#GD

#LI-JC1

PPDLABS

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: Identified expertise in one or more specialized areas relevant to QA activities, e.g. batch record review, root cause analysis, TQM May require knowledge of QP Release activities Knowledge of GxP and appropriate regional regulations and guidelines Working knowledge of project based or internal GxP audits and vendor audits Excellent oral and written communication skills Strong problem solving, risk assessment and impact analysis abilities Experience in root cause analysis and CAPA management Ability to remain flexible and prioritize competing demands/work load Ability to multitask whilst still delivering high quality results Management Role: No management responsibility

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 plans Community connections and activities including philanthropic engagement, volunteer service projects and more Other 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 qualification Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: Identified expertise in one or more specialized areas relevant to QA activities, e.g. batch record review, root cause analysis, TQM May require knowledge of QP Release activities Knowledge of GxP and appropriate regional regulations and guidelines Working knowledge of project based or internal GxP audits and vendor audits Excellent oral and written communication skills Strong problem solving, risk assessment and impact analysis abilities Experience in root cause analysis and CAPA management Ability to remain flexible and prioritize competing demands/work load Ability to multitask whilst still delivering high quality results Management Role: No management responsibility

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 plans Community connections and activities including philanthropic engagement, volunteer service projects and more Other 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

Job posted: 2020-09-08

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