Quality Assurance Associate

1 month ago

London, United Kingdom IAG, Image Analysis Group Full time

**QUALITY ASSURANCE ASSOCIATE (GCP)**

**Start Date**:
Immediately

Monday 03-JUL-2023

**Salary**:
£25,000 - £30,000 + Quarterly Bonus + Benefits

**Location**:
UK (Hybrid)

**Employment Type**:
Full Time

This opportunity is for a confident, detail-oriented and knowledgeable **Quality**
**Assurance Associate **to join a fast growing team, contributing to the advancement of medical research and ensure the highest standards of quality in clinical trials.

**IAG, Image Analysis Group** is the expert imaging company, supporting drug trials for biotech and pharma clients. Our specialisation is in oncology, neurology and musculoskeletal research. We work from the very early stages of development all the way to the global phase three trials. You will be working with IAG’s distributed teams, scientific experts and radiologists.

**In this role, you will be responsible for implementing, maintaining and continuously improving the company’s Quality Management System (QMS) to ensure the clinical trials are compliant with regulatory requirements and that patient safety and data integrity are respected.**

**WHAT YOU’LL BE DOING**
- Implement the company’s quality assurance policies and procedures
- Assist to assure IAG continues to meet applicable quality standards
- Provide guidance and support to clinical trial personnel regarding regulatory requirement, Good Quality Practice (GCP/GxP), industry standards (ISO13485) and best practices
- Assist with tracking, reviewing and approving QMS Documents using the document control software
- Assist with the preparation and conduct of internal audits, regulatory inspections, re-certification audits and customer audits
- Develop and deliver training sessions and workshops to enhance awareness and understanding of quality assurance principles within the company
- Assist the tracking, assessing, reviewing, approving and closing of corrective and preventative actions (CAPAs)
- Participate in the development and review of Standard Operating Procedures (SOPs) and Quality Controlled Documents (QCDs) to ensure compliance with applicable regulations, standards and guidelines
- Assist with the preparation, review, and formatting of documentation, reports and materials for the quarterly Quality Management Review (QMR) Meetings

**REQUIREMENTS AND EXPERIENCE**
- Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
- Minimum of 1 year of experience in clinical quality assurance within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Knowledge of clinical trial processes, protocols, and documentation
- Knowledge of regulatory requirements, guidelines, and standards relevant to
- clinical trials (e.g., EU regulation 536/2014, ICH-GCP, 21 CFR Part 11, ISO134850)
- Experience in conducting audits and/or inspections, including knowledge of auditing techniques and principles

**SKILLS AND ATTRIBUTES**
- Excellent attention to detail and ability to identify potential issues or discrepancies
- Effective organization, communication, and team orientation skills
- Strong analytical and problem-solving skills
- Effective communication and interpersonal skills to collaborate with cross
- functional teams
- Excellent training capabilities
- Ability to work independently and handle multiple tasks simultaneously

**ABOUT IAG**
We are an international diverse organization. Working for IAG, will give you an opportunity to work internationally, learn from your colleagues, meet the world’s top professionals in clinical research and academia and make a real impact

**Benefits**:

- Bonus scheme, based on your performance and company’s achievements
- Private health and other benefits
- Pension contribution and plans
- Company events & social hours
- Hybrid working depending on your location
- Opportunity to learn, collaborate internationally and rapidly advance your career

**Salary**: £25,000.00-£30,000.00 per year

**Benefits**:

- Company pension
- Private medical insurance

Schedule:

- Monday to Friday

Supplemental pay types:

- Quarterly bonus

Work Location: Hybrid remote in London, W6 8DL

Application deadline: 03/07/2023
Reference ID: QUALITY ASSURANCE ASSOCIATE (GCP)

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