Clinical Quality Assurance Specialist

**JOB DESCRIPTION**:**
Title: QA Specialist - Central Labs**

**Division / Dept.: Quality Assurance and Compliance**

**Location: Zaventem (Remote Based)**

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

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

**Summarized Purpose**:

- Provides expertise, leadership and guidance to operational teams assigned to respond to quality events as problem statements, investigations, root cause analysis, corrective and preventive actions and effectiveness checks are developed, documented and implemented as a member of the Central Lab QA Quality Risk Management team.
- Supports risk assessment and analysis, metrics and reporting and data entry.
- Performs tasks in support of the larger Central Lab QA team, such as those pertaining to audits, inspections and procedural document reviews, as needed and required.

**Video links**:
**PPD LinkedIn Video Landing Page**:
LI-MS1

**Job Qualification**:**
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

At PPD clinical research services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

Our 4i Values:
Integrity - Innovation - Intensity - Involvement

**Diversity Statement**:
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.