Compliance Specialist

3 weeks ago

Gaithersburg, United States AstraZeneca Full time

**Compliance Specialist (Integrated Bioanalysis)**

**Bold Disruptors. Push the boundaries of science. Fearlessly break new ground.**

Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We’re looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences.

**What we do**

We are a global, science-led Biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.

**Why we love it**

The future is bright at AstraZeneca as we bring ground-breaking therapies for complex disease to patients with critical needs. Scientific innovations are at the core of what we do across our industry leading portfolio which drive exciting opportunities and varied work. We’re on an exciting journey to pioneer the future of healthcare

**About the role**

As part of the Regulatory Bioanalysis Team in Integrated Bioanalysis (iBA), you will be responsible for supporting the activities and operations of the GLP and GCP certified laboratories and will be reviewing bioanalytical documentations, data, and reports to ensure quality. You will also prepare computer system validation plans and reports, support study set up and closeout activities, and support the regulatory compliance of our operations. You will interact with internal stakeholders and support outsourced studies. You will be working with a dynamic team in a matrixed environment and will need to manage stakeholder expectations whilst working with bioanalytical scientist colleagues or our partnered labs. You will have the opportunity to have an immediate effect on our deliverables and a lasting impact to our diverse pipeline.

The iBA group within Clinical Pharmacology and Safety Sciences provides broad discovery, preclinical, and clinical support including life cycle management across all therapeutic areas enabling pipeline delivery, decision making, innovation and advancement to improve the lives of patients through life-changing medicines.

**What you’ll do**

You will be located at our research hub in Gaithersburg, MD as part of a dynamic laboratory team, where you will work alongside experienced bioanalytical scientists as well as lab compliance and operation teams to support a range of the portfolio.

In this role you will:

- Conduct QC review of bioanalytical documentations, study data, study reports and TMFs
- Prepare instrument/computer system validation plans and reports
- Archive study binders, validation binders, and study data
- Prepare study reports to ensure the quality of deliverables
- Support study set up, DTA review, data delivery and study close out
- Assist with preparation for audit and regulatory inspections
- Ensure the compliance with GLP/GCP regulations, SOPs, AZ standards and polices

**Education & Experience Requirements**:

- Education: _BS or MS in Biochemistry/Chemistry or related field
- Experience: _BS or MS degree and 5+ years of relevant experience in GxP compliant Laboratories

**Required Skills & Experience**:

- Work experience in a regulated environment such as GLP, GCP or GMP.
- Experience with QC review of study documentations and data such as study binders, study data, data specifications, study reports and master files (TMF).
- Experience with preparing / writing plans or reports for studies or computer / instrument validation.
- Meticulous attention to detail and approach to documentation.
- Good organizational and planning skills - ability to control and coordinate own work and work to assigned deadlines.
- Good time management skills, ability to be flexible and handle multiple responsibilities and tasks on a regular basis.
- Ability to work independently and as part of a team.
- Clear, concise written and spoken communication skills.
- Strong collaborative mentality, flexible to work on assigned projects.

**Desired Skills & Experience**:

- Familiar with data or document management systems such as LIMS, Veeva Vault in regulatory setting.
- Experience of managing study documentations within bioanalytical Labs.
- Enthusiastic, proactive, and quick to learn.
- Good problem-solving capabilities and confidence to react promptly to deliver the best support possible.
- Experience of working in a cross-matrix organization is desirable.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.

**Why AstraZeneca?**

At AstraZeneca when we see an opportunity for chang

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